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# ACRO

Innovate. Advocate. Collaborate.

## Sitemaps

- [XML Sitemap](https://www.acrohealth.org/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [ACRO Releases its State of the Industry Report](https://www.acrohealth.org/2026/03/24/acro-releases-its-state-of-the-industry-report/) - The State of the Industry Report: ACRO Member Impact on Drug Development In early 2026, ACRO conducted an online survey of its member companies evaluating their activities throughout 2025. The survey was held among 15 ACRO member companies to better understand the activities and demographic makeup of ACRO member organizations and to demonstrate the impact
- [ACRO Welcomes Clay Alspach as New Executive Director](https://www.acrohealth.org/2026/01/27/acro-welcomes-clay-alspach-as-new-executive-director/) - WASHINGTON, DC (January 27, 2026) – Clay Alspach has joined the Association of Clinical Research Organizations (ACRO) as its new Executive Director. Alspach stated, “I am excited to step into the role of ACRO Executive Director. I look forward to working with the ACRO staff, the Board, and the committees in this new role. It is an honor and
- [ACRO Announces Doug Peddicord Retirement after 24 Years](https://www.acrohealth.org/2026/01/12/acro-announces-doug-peddicord-retirement-after-24-years/) - WASHINGTON, DC (January 12, 2026) – Doug Peddicord, Executive Director of the Association of Clinical Research organizations (ACRO), has announced he will step down from his role in January 2026, having completed his 24th year leading the non-profit trade association representing clinical research and technology organizations. “It is nearly impossible to describe the impact that
- [ACRO Announces 2026 Officers](https://www.acrohealth.org/2025/12/10/acro-announces-2026-officers-and-new-members/) - WASHINGTON, DC (December 10, 2025) – Today, ACRO announced that its Board of Directors elected Cassandra “Sandy” Kennedy, Chief Quality, Regulatory Affairs, and Sustainability Officer at Fortrea, as Chair of the Association, effective January 1, 2026. Gadi Saarony, Chief Executive Officer at Advarra, was elected Vice-Chair of the Association. In addition, the Board of Directors
- [Good Clinical Podcast Season 3](https://www.acrohealth.org/2025/04/18/good-clinical-podcast-season-3/) - ACRO’s Good Clinical Podcast is Back for Season 3! ACRO’s Good Clinical Podcast is back for Season 3 on Tuesday, April 22. Leaders from across the clinical research industry join the podcast to discuss the topics that will be key to promoting innovation and driving continued improvement in the conduct of clinical trials in the year
- [ACRO Announces 2025 Officers and New Members](https://www.acrohealth.org/2024/12/19/acro-announces-2025-officers-and-new-members/) - WASHINGTON, DC – Washington DC – ACRO today announced that its Board of Directors elected Jim Reilly, Executive Vice President, Development Cloud Strategy at Veeva, as Chair of the Association, effective January 1, 2025. Cassandra “Sandy” Kennedy, Chief Quality, Regulatory Affairs, and Sustainability Officer at Fortrea, was elected Vice-Chair. In addition, the Board of Directors
- [ACRO Releases Publication Showcasing Benefits of Centralized Monitoring Implementation Through Real-World Use Case](https://www.acrohealth.org/2024/12/12/acro-releases-publication-showcasing-benefits-of-centralized-monitoring-implementation-through-real-world-use-case/) - WASHINGTON, DC – Today, ACRO’s RBQM Working Group has announced the publication of its latest RBM/RBQM paper, Risk-Based Quality Management: A Case for Centralized Monitoring, in DIA’s Therapeutic Innovation & Regulatory Science journal. In this new publication, ACRO’s RBQM Working Group provides a real-life example of centralized monitoring implementation using a clinical trial from clinicaltrials.gov
- [ACRO Announces Diversity and Inclusion Site Resource Grants Program](https://www.businesswire.com/news/home/20240415250064/en#new_tab) - The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities.
- [Peyton Howell Speaks to ACRO’s 2024 Outlook](https://mailchi.mp/6ef9d0547d59/acro-transcelerate-biopharma-release-new-infographic-14158776?e=[UNIQID]#new_tab) - In ACRO’s 2024 outlook, Peyton Howell, Chief Operating and Growth Officer at Parexel and chair of ACRO’s board of directors, speaks to how ACRO’s members continue to come together to meet the needs of the moment and make trials better for patients.
- [ACRO Releases Key Highlights from Survey on Americans’ Views on Clinical Trials and Clinical Research](https://mailchi.mp/ab2b67251500/acro-transcelerate-biopharma-release-new-infographic-14151344?e=[UNIQID]#new_tab) - ACRO has released key highlights from a recent survey focused on Americans’ views on clinical trials and clinical research. Commissioned by Research!America in partnership with ACRO, the October 2023 national survey captures a snapshot of attitudes about clinical research.
- [ACRO & TransCelerate BioPharma Release Resource on Risk Management - Key Changes in ICH E6(R3)](https://www.acrohealth.org/resource/key-risk-management-changes-in-good-clinical-practice-ich-e6r3/#new_tab)
- [ACRO & Research!America Survey Americans' On Clinical Trials And Research](https://mailchi.mp/bc893eca308f/acro-researchamerica-survey-americans-on-clinical-trials-and-research?e=[UNIQID]#new_tab)
- [ACRO AI/ML Committee Releases Principles For Responsible AI](https://mailchi.mp/61cb02352d79/acro-aiml-committee-releases-principles-for-responsible-ai?e=[UNIQID]#new_tab)
- [Listen Now to Season 1 of ACRO's Good Clinical Podcast](https://mailchi.mp/a4d64fccdce0/listen-now-acros-good-clinical-podcast-episode-13834308#new_tab)
- [ACRO Submits Comment To FDA On DCTs](https://mailchi.mp/7a1f93556f37/dct-qanda-latest-resource-13817347#new_tab)
- [ACRO AI/ML Committee Releases Principles for Responsible AI](https://www.acrohealth.org/2023/12/20/acro-ai-ml-committee-releases-principles-for-responsible-ai/) - WASHINGTON--Representing clinical research organizations (CROs) and clinical technology companies actively engaged in developing and deploying AI tools to support and improve drug development functions, ACRO is pleased to announce the release of ACRO’s Principles for Responsible AI. Drafted by a team of CRO and technology subject matter experts, the ACRO Principles articulate an approach to the
- [ACRO Announces 2024 Officers and New Members](https://www.acrohealth.org/2023/12/12/acro-announces-2024-officers-and-new-members/) - WASHINGTON, DC – Washington DC – ACRO today announced that its Board of Directors has elected Peyton Howell, Chief Operating & Growth Officer at Parexel, as Chair of the association effective Jan. 1, 2024. Lisa Moneymaker, Chief Technology Officer & Chief Product Officer at Saama, was elected Vice Chair. In addition, the Board of Directors
- [OPINION: Keep Our Foot on the Gas for Clinical Trial Diversity](https://www.acrohealth.org/2022/08/08/opinion-keep-our-foot-on-the-gas-for-clinical-trial-diversity/) - The below is an Op-Ed authored by ACRO Chair, Jackie Kent, for MedPage Today on August 6, 2022. Read the full article here. The COVID-19 pandemic sparked rapid innovation and adoption of new methodologies and practices across clinical trials. It also allowed the world to see the difficulty of ensuring diversity and access to those
- [ACRO & TransCelerate Issue a Joint Statement on Considerations while Developing Clinical Study Reports (CSRs)](https://www.acrohealth.org/2022/09/12/acro-transcelerate-issue-a-joint-statement-on-considerations-while-developing-clinical-study-reports-csrs/) - Our member companies have faced widespread clinical trial disruptions in the past few years - from the global pandemic, to the war in Ukraine. We developed a recommendation for how sponsors and CROs should report study disruptions in a Clinical Study Report (CSR). Click Here to Read the Considerations Statement
- [Medidata White Paper: COVID-19 and  Clinical Trials: The Medidata Perspective (#5)](https://www.acrohealth.org/wp-content/uploads/2020/06/COVID19-Response6.0_Clinical-Trials_2020615_v4.pdf#new_tab)
- [Parexel Blogpost: Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19](https://regulatory-access.parexel.com/blogs/using-risk-assessment-decision-tree-models-to-maintain-safety-and-data-validity-in-clinical-trials-during-covid-19-4#new_tab)
- [Signant Health White Paper: Expanded Role of Patient Engagement in Clinical Research During the COVID-19 Pandemic](https://www.signanthealth.com/wp-content/uploads/2020/05/COVID-19-Patient-Engagement-Curtin.pdf#new_tab)
- [Veeva White Paper: Guidance for Remote Monitoring](https://www.veeva.com/resources/guidance-for-remote-monitoring/?guidance-for-remote-monitoring/?#new_tab)
- [Bioclinica Blogpost: Clinical Trial Disruption Due to COVID-19: How Bioclinica Is Responding](https://www.bioclinica.com/blog/clinical-trial-disruption-due-covid-19-how-bioclinica-responding#new_tab)
- [PPD Blogpost: The Future of Clinical Research: Digitally Transforming What’s Possible](https://www.ppd.com/blog/the-future-of-clinical-research-digitally-transforming-whats-possible/#new_tab)
- [ERT Survey Report: Virtual Trials & The State of Clinical Research](https://virtualtrials.ert.com/virtual-trials-clinical-research-report/#new_tab)
- [Oracle Health Sciences Report: 2019 Market Research Report: The Use of Virtual Components in Clinical Trials](https://www.oracle.com/a/ocom/docs/industries/life-sciences/cns-summit-report.pdf#new_tab)
- [IQVIA Publication: Modernizing Regulatory Evidence With Trials and Real-World Studies](https://www.iqvia.com/library/publications/modernizing-regulatory-evidence-with-trials-and-real-world-studies#new_tab)
- [Syneos Health Podcast: A Regulatory Roadmap for Real World Evidence](https://www.syneoshealth.com/insights-hub/syneos-health-podcast-regulatory-roadmap-real-world-evidence#new_tab)
- [Covance White Paper: The Role of Real-World Evidence in Supporting A Product's Value Story](https://www.covance.com/content/dam/covance/assetLibrary/whitepapers/Real-World-Evidence-A4-WPCMA011.pdf#new_tab)
- [Parexel Blogpost: Risk-Based Monitoring: The Right Solution for a Turbulent Present and an Uncertain Future](https://regulatory-access.parexel.com/covid-19/risk-based-monitoring-the-right-solution-for-a-turbulent-present-and-an-uncertain-future-4#new_tab)
- [PRA Health Sciences Case Study: Succeeding with a Risk-Based Approach](https://prahs.com/insights/succeeding-with-a-risk-based-approach#new_tab)
- [ICON White Paper: Getting Ready for ICH E6 (R2)](https://www.iconplc.com/insights/transforming-trials/risk-based-monitoring/#new_tab)
- [Medidata Podcast: Clinical Minds Podcast: What is the Data Telling Us?](https://www.medidata.com/en/blog/clinical-minds-podcast-what-is-the-data-telling-us/#new_tab)
- [Oracle Health Sciences Blogpost: Automation of Laboratory Reports is Essential to Personalized Medicine](https://blogs.oracle.com/health-sciences/automation-of-laboratory-reports-is-essential-to-personalized-medicine#new_tab)
- [Veeva Whitepaper: Driving AI Success with a Modern Approach to Data Management](https://go.veeva.com/l/28972/2019-10-15/8pcm12#new_tab)
- [ERT Blogpost: FDA Guidance Overview: Assessing Symptoms in Clinical Trials Aimed to Prevent and Treat COVID-19](https://www.ert.com/blog/fda-guidance-overview-assessing-symptoms-in-clinical-trials-aimed-to-prevent-and-treat-covid-19/#new_tab)
- [Medidata Blogpost: AI and Advanced Analytics: Delivering Value for Clinical Trials During COVID-19](https://www.medidata.com/en/blog/ai-and-advanced-analytics-delivering-value-for-clinical-trials-during-covid-19#new_tab)
- [Parexel Introduces Discussions on Diversity Research to Promote Diversity in Clinical Trials](https://www.parexel.com/news-events-resources/news/current/parexel-introduces-discussions-diversity-research-promote-diversity-clinical-trials#new_tab)
- [Parexel Podcast: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19](https://www.parexel.com/news-events-resources/blog/podcasts/episode-13-new-pragmatism-clinical-trials-investment-and-regulations-post-covid-19#new_tab)
- [New ACRO Report Quantifies Benefits of RBM for Quality Reviews](https://www.acrohealth.org/2019/10/17/new-acro-report-quantifies-benefits-of-rbm-for-quality-reviews/) - A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. The report, Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies, found that when a company reviews data through a centralized system using the RBM model, CROs
- [A Consistent Approach to Risk Based Quality Management: Collaboration is Key](https://www.acrohealth.org/2019/10/24/a-consistent-approach-to-risk-based-quality-management-collaboration-is-key/) - Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to inform decisions about trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, sponsors must identify proactive ways to incorporate quality into study design, rather than taking
- [Josef von Rickenbach 2013 ACRO Chairman](https://www.acrohealth.org/2013/01/10/josef-von-rickenbach-2013-acro-chairman/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org Josef von Rickenbach of PAREXEL International Elected 2013 ACRO Chairman January 10, 2013 - WASHINGTON, DC – The Association of Clinical Research Organizations is pleased to announce that its Board of Directors has elected Josef von Rickenbach, founder, Chairman and CEO of PAREXEL International, as 2013 Chairman and Ciaran Murray, CEO of ICON, as Vice Chairman.
- [ACRO Comments on Bad Pharma](https://www.acrohealth.org/2013/02/05/acro-comments-on-bad-pharma/) - ACRO Statement on Bad Pharma FEBRUARY 4, 2013, WASHINGTON, DC -- Association of Clinical Research Organizations (ACRO) Vice President of Public Affairs John Lewis today made the following statement regarding the release of Dr. Ben Goldacre’s new bookBad Pharma: “In Bad Pharma Dr. Goldacre raises many issues, some of them legitimate and none of them new. Our comments
- [ACRO Launches New Video Series](https://www.acrohealth.org/2013/05/09/acro-launches-new-video-series/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org ACRO Launching New Video Series With Health Coalition Leaders May 9, 2013 - WASHINGTON, DC – The Association of Clinical Research Organizations is introducing a new series of videos featuring the leaders of prominent healthcare interest groups. The first two videos feature Ladd Wiley, Executive Director of the Alliance for a Stronger FDA, and Michael Reilly,
- [ACRO Joins Coalition of Small Business Innovators](https://www.acrohealth.org/2013/05/21/acro-joins-coalition-of-small-business-innovators/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org ACRO Joins Coalition of Small Business Innovators CSBI Encourages a Tax Code that Promotes Economic Growth and Creates Jobs Washington, DC (May 21, 2013) – The Association of Clinical Research Organizations announced today it has joined the Coalition of Small Business Innovators (CSBI). CSBI is a national, non-partisan coalition of organizations dedicated to
- [Video Series on R&D, Innovation, Economic Growth](https://www.acrohealth.org/2013/08/12/video-series-on-rd-innovation-economic-growth/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org New ACRO Video Series Spotlights R&D, Innovation, Economic Growth August 12, 2013 - WASHINGTON, DC – A new series of videos from theAssociation of Clinical Research Organizations focuses on encouraging innovation, efficient research that emphasizes the patient, and the economic growth that comes from bilateral cooperation between two large economies. “The new
- [Ciaran Murray of ICON Elected 2014 ACRO Chairman](https://www.acrohealth.org/2014/01/13/ciaran-murray-of-icon-elected-2014-acro-chairman/) - January 14, 2014 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Ciaran Murray, CEO of ICON plc (NASDAQ:ICLR), as 2014 Chairman and Jamie Macdonald, CEO of INC Research as Vice Chairman. “I am honoured to lead ACRO at this time when clinical research organizations are increasingly being recognized
- [ACRO Testifies at USITC on India Policies](https://www.acrohealth.org/2014/02/18/acro-testifies-at-usitc-on-india-policies/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org ACRO Testifies Before U.S. International Trade Commission On Effects of India Industrial Policies on Economy February 18, 2014 - WASHINGTON, DC – Members of the Association of Clinical Research Organizations (ACRO) have seen their clinical trials activity in India decrease more than 60 percent since 2010 as a result of a “confusing, inconsistent
- [Noonan to Head Global Regulatory Policy](https://www.acrohealth.org/2014/03/18/noonan-to-head-global-regulatory-policy/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org Karen Noonan to Head Global Regulatory Policy for ACRO Decade of health policy, alliance development and legislative experience March 18, 2014 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that Karen A. Noonan has joined the association in the newly created position of Vice President, Global
- [Association Of Clinical Research Organizations Launches New Responsive-Design Website](https://www.acrohealth.org/2014/06/03/association-clinical-research-organizations-launches-new-responsive-design-website/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org Reimagined www.acrohealth.org and New RebelMouse Page Showcase the Work, Innovation and Excellence of ACRO Members June 3, 2014 - Washington, D.C. – The Association of Clinical Research Organizations (ACRO) today is proud to unveil its newly reimagined, responsive-design website, www.acrohealth.org. The site, which automatically adjusts to fit any browser window and
- [ACRO Provides Comments on 21st Century Cures](https://www.acrohealth.org/2014/07/07/acro-provides-comments-21st-century-cures/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org Focus on EHRs, Tax Incentives, FDA Innovation July 8, 2014 - Washington, D.C. – The Association of Clinical Research Organizations (ACRO) has provided the House Energy & Commerce Committee with its first set of recommendations for streamlining the drug development process. ACRO’s recommendations focus on three themes: Encouraging the use
- [ACRO Strongly Endorses COMPETE Act](https://www.acrohealth.org/2014/07/31/acro-strongly-endorses-compete-act/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org R&D Bill Introduced by Senator Carper will Draw Medical Research Jobs to the U.S. July 31, 2014 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) released the following statement in support of the COMPETE Act of 2014 introduced today by Senator Tom Carper (D-DE): “The COMPETE Act
- [September Is Clinical Research Innovation Month](https://www.acrohealth.org/2014/09/10/september-clinical-research-innovation-month/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org Washington, D.C. - The Association of Clinical Research Organizations (ACRO) today is proud to announce that Senator Tom Carper (D-DE) and Congressman Fred Upton (R-MI) have been named its 2014 Legislators of the Year, to coincide with ACRO's first-ever Innovation Month this September. Carper recently introduced the COMPETE Act and
- [ACRO Survey Shows Strong Growth of CRO Industry](https://www.acrohealth.org/2014/09/16/acro-survey-shows-strong-growth-cro-industry/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org Members boast 100,000 employees, conduct clinical trials in 142 countries September 17, 2014 - WASHINGTON, DC – Members of the Association of Clinical Research Organizations (ACRO) have more than doubled in size in the past 10 years and now employ more than 100,000 research professionals worldwide with a global payroll
- [CROs an Innovation Partner in Clinical Trials](https://www.acrohealth.org/2014/10/08/cros-innovation-partner-clinical-trials/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org New ACRO Report Details Cost Saving and Time Saving Clinical Trial Innovations Championed by CROs Washington, D.C.—As a cap to Clinical Research Innovation Month, the Association of Clinical Research Organizations (ACRO) today released a report titled Clinical Research: A Legacy of Innovation, A Future of Transformed Medicine which showcases advancements
- [ACRO Establishing CRO Forum To Interact with TransCelerate Biopharma Inc.](https://www.acrohealth.org/2014/10/27/acro-establishing-cro-forum-interact-transcelerate-biopharma-inc/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org WASHINGTON, DC – The Association of Clinical Research Organizations today announced plans to constitute a CRO Forum in order to provide a formal mechanism for the CRO industry to furnish input into the work of TransCelerate BioPharma Inc. The CRO Forum, expected to commence operation in January 2015, is open
- [Jamie Macdonald of INC Research Elected 2015 ACRO Chairman](https://www.acrohealth.org/2015/01/07/jamie-macdonald-inc-research-elected-2015-acro-chairman/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Jamie Macdonald, CEO of INC Research (NASDAQ: INCR), as its 2015 Chairman and David Simmons, Chairman and CEO of PPD, as Vice Chairman. “I am pleased to lead ACRO
- [ACRO Statement on Release of 21st Century Cures Discussion Document](https://www.acrohealth.org/2015/01/27/acro-statement-release-21st-century-cures-discussion-document/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org January 27, 2015 – WASHINGTON, DC – Doug Peddicord, Ph.D., Executive Director of the Association of Clinical Research Organizations (ACRO), released the following statement on the potential policy proposals unveiled today by House Energy and Commerce Committee Chairman Fred Upton (R-MI). “ACRO commends Chairman Fred Upton (R-MI) and Rep. Diana
- [BioClinica, Theorem Clinical Research Newest Members of ACRO, BioClinica CEO Dr. John Hubbard joins ACRO Board](https://www.acrohealth.org/2015/01/29/bioclinica-theorem-clinical-research-newest-members-of-acro-bioclinica-ceo-dr-john-hubbard-joins-acro-board/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org January 29, 2015 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to welcome BioClinica® and Theorem Clinical Research into its membership. BioClinica is joining as a regular member of ACRO and Dr. John Hubbard, President and CEO, will become a member of the ACRO Board
- [ACRO Strongly Supports COMPETE Act; Commends Senators Carper and Toomey for Their Co-Sponsorship](https://www.acrohealth.org/2015/02/25/acro-strongly-supports-compete-act-commends-senators-carper-and-toomey-for-their-co-sponsorship/) - February 25, 2015 – WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) released the following statement in support of the bi-partisan COMPETE Act of 2015 (S. 537) introduced yesterday by Senators Tom Carper (D-DE) and Patrick Toomey (R-PA): “We thank Senators Carper and Toomey for their thoughtful approach to modernizing Federal tax policy
- [ACRO Holds Initial Meeting of CRO Forum, Begins Two-Way Dialogue With TransCelerate](https://www.acrohealth.org/2015/03/09/acro-holds-initial-meeting-of-cro-forum-begins-two-way-dialogue-with-transcelerate/) - March 9, 2015 - WASHINGTON, DC – The Association of Clinical Research Organizations, whose members account for approximately two-thirds of contract clinical development services, held the inaugural meeting of the previously announced CRO Forum in Washington, DC. The Forum was established in October 2014 as the primary vehicle for interaction between the CRO industry and
- [ACRO Praises Reps. Meehan, Holding, Butterfield For Introducing Domestic Research Enhancement Act](https://www.acrohealth.org/2015/05/21/acro-praises-reps-meehan-holding-butterfield-for-introducing-domestic-research-enhancement-act/) - May 21, 2015 (Washington, DC) – Jamie Macdonald, Chairman of the Association of Clinical Research Organizations (ACRO) and CEO of INC Research, today issued the following statement in support of the introduction of the Domestic Research Enhancement Act of 2015 (H.R. 2481), which modernizes the research and development tax credit to recognize the important role
- [Statement by ACRO Executive Director Doug Peddicord On House Passage of 21st Century Cures Act](https://www.acrohealth.org/2015/07/10/statement-by-acro-executive-director-doug-peddicord-on-house-passage-of-21st-century-cures-act/) - July 10, 2015 (Washington, DC) – The Association of Clinical Research Organizations (ACRO) is pleased to see the passage of the 21st Century Cures Act, which will assist in the modernization of clinical trials that help bring new treatments to patients in need. We are especially encouraged that the legislation calls for enhancements to clinicaltrials.gov
- [Patient Centered Drug Development At Center of CRO Innovation Month](https://www.acrohealth.org/2015/09/08/patient-centered-drug-development-at-center-of-cro-innovation-month/) - Washington, D.C. – The Association of Clinical Research Organizations (ACRO) is kicking off its second annual CRO Innovation Month with the theme of “Transforming Patient Centered Drug Development.” A series of videos describing how CROs are educating and engaging patients while implementing their suggestions into the clinical research process will debut this month with thoughts
- [ACRO Welcomes Nomination of Califf As FDA Commissioner](https://www.acrohealth.org/2015/09/17/acro-welcomes-nomination-of-califf-as-fda-commissioner/) - Washington, D.C. – Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO), today issued the following statement regarding President Obama’s nomination of Dr. Robert Califf to serve as the next Commissioner of the Food and Drug Administration: “ACRO welcomes the nomination of Dr. Califf as FDA Commissioner. We have worked closely
- [ACRO Names Supporters of Research & Development, 21st Century Cures  As Legislators of the Year](https://www.acrohealth.org/2015/09/29/acro-names-supporters-of-research-development-21st-century-cures-as-legislators-of-the-year/) - Washington, D.C. – The Association of Clinical Research Organizations (ACRO), is very pleased to name its two 2015 Legislators of the Year, U.S. Representatives Patrick Meehan (R-PA) and Diana DeGette (R-CO). The announcement coincides with the second-annual CRO Innovation Month. This year’s theme is “Transforming Patient Centered Drug Development.” Rep. Meehan has been a long-time
- [David Simmons of PPD Elected 2016 ACRO Chairman](https://www.acrohealth.org/2016/01/06/david-simmons-of-ppd-elected-2016-acro-chairman/) - January 6, 2016 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected David Simmons, Chairman and CEO of PPD, as its 2016 Chairman, and John Hubbard, President and CEO of Bioclinica, as Vice Chairman. “ACRO plays a vital role in promoting the
- [Association of Clinical Research Organizations  Launches Real World Data Video Series](https://www.acrohealth.org/2016/02/09/association-of-clinical-research-organizations-launches-real-world-data-video-series/) - February 9, 2016 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) today launched a new video series examining the definitions and uses of “real world data.” ACRO slated the release of the videos to coincide with a national health policy conversation revolving more and more around “the cancer moon-shot,” personalized medicine, “big
- [Survey Points to Wearable Technology, Social Media Recruitment As Leading Trends in Clinical Trials](https://www.acrohealth.org/2016/05/09/survey-points-to-wearable-technology-social-media-recruitment/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org May 10, 2016 (Washington, DC) – A rapid increase in the use of wearable technology and an upsurge in social media for patient recruitment are two of the more prevalent clinical trial technology trends, according to a new survey from the Association of Clinical Research Organizations (ACRO). Full details of
- [ACRO Applauds Passage of 21st Century Cures Act](https://www.acrohealth.org/2016/12/07/acro-applauds-passage-of-21st-century-cures-act/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org December 7, 2016 (Washington, DC) – Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO), released the following statement on passage of the 21st Century Cures Act by the House and Senate. “The Association of Clinical Research Organizations (ACRO) commends the House and Senate for passing
- [John Hubbard of Bioclinica Elected 2017 ACRO Chairman, Medidata Joins Member Companies](https://www.acrohealth.org/2017/01/30/john-hubbard-bioclinica-elected-2017-acro-chairman-medidata-joins-member-companies/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org John Hubbard of Bioclinica Elected 2017 ACRO Chairman Medidata Joins Member Companies January 30, 2017 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected John Hubbard, Ph.D., President and CEO of Bioclinica, as 2017 Chairman and John
- [Dear Director Collins and Director Brennan](https://www.acrohealth.org/2017/02/21/dear-director-collins-director-brennan/) - February 21, 2017 Dr. Francis S. Collins Director, National Institutes of Health Dr. Patricia Flatley Brennan Director, National Library of Medicine Re: Section 2054, 21st Century Cures Act/ClinicalTrials.gov Dear Director Collins and Director Brennan: The undersigned organizations share a commitment to heightening clinical trial awareness, increasing clinical trial participation and promoting safety, quality and efficiency
- [ACRO Strongly Endorses Domestic Research Enhancement Act of 2017](https://www.acrohealth.org/2017/04/04/acro-strongly-endorses-domestic-research-enhancement-act-2017/) - Contact: John Lewis 202.464.9340 jlewis@acrohealth.org April 4, 2017 (Washington, DC) – The Domestic Research Enhancement Act of 2017 (H.R. 1234), which modernizes the research and development tax credit to recognize the essential role contract research now plays in the development of new pharmaceuticals, biologics and medical devices, has been introduced by Rep. Pat Meehan (R-PA)
- [Right to Try ACRO Policy Statement](https://www.acrohealth.org/2017/05/22/right-try-acro-policy-statement/) - Over the past few years, legislation that would give terminally ill patients access to unapproved treatments, known as “Right-to-Try,” has gained momentum in a number of states and now in the U.S. Congress. As the organization representing the world’s leading clinical research organizations that each year conduct more than 7,000 clinical trials involving 1.3 million
- [Majority of Americans Open to Clinical Trial Participation If Recommended by a Doctor, New Study Finds](https://www.acrohealth.org/2017/09/06/majority-americans-open-clinical-trial-participation-recommended-doctor-new-study-finds/) - WASHINGTON--(BUSINESS WIRE)--The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials. The study, funded in part by ACRO and conducted by Zogby Analytics, surveyed 1,000 adults nationwide in July 2017 and found that an overwhelming majority (86%) believe that doctors should discuss clinical trials
- [ACRO Testifies About Clinical Trials In New Jersey](https://www.acrohealth.org/2017/10/23/acro-testifies-clinical-trials-new-jersey/) - Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of the New Jersey Division of Consumer Affairs about a regulation that, if adopted, would have a devastating impact on the availability of clinical trials for patients in New Jersey and cripple the ability
- [ACRO Urges Modernization of the R&D Tax Credit](https://www.acrohealth.org/2017/11/14/acro-urges-modernization-rd-tax-credit/) - WASHINGTON - November 14, 2017 - As the Senate begins debate on a tax reform bill, the clinical research industry hopes that attention will be given to a small but substantive issue - updating a tax code provision that has had strong bipartisan support for more than 30 years. In 1981 Congress created the research
- [John Ratliff of Covance Elected 2018 ACRO Chairman](https://www.acrohealth.org/2018/01/25/john-ratliff-covance-elected-2018-acro-chairman/) - WASHINGTON--(BUSINESS WIRE)--The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected John Ratliff, CEO of Covance Drug Development, as 2018 Chairman and Cynthia Verst, President, Clinical Operations at IQVIA, as Vice Chairman. Prior to being named Covance’s CEO in September 2016, Mr. Ratliff was President and CEO of HUYA Bioscience
- [British MP Benn talks Brexit challenges and the future of UK clinical research industry](https://www.acrohealth.org/2018/04/18/british-mp-benn-talks-brexit-challenges-and-the-future-of-uk-clinical-research-industry/) - The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit, on 13 April the UK’s major clinical research organizations (CROs) met with the Rt Hon Hilary Benn (Labour - Leeds Central) to tour Covance’s research facilities in Leeds and discuss the implications of
- [ACRO Opposes Fatally-Flawed Right-To-Try Legislation](https://www.acrohealth.org/2018/05/18/acro-opposes-fatally-flawed-right-to-try-legislation/) - In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research organizations, unanimously approved a statement explaining ACRO’s deep concerns about proposed federal Right-To-Try legislation. While promising hope to patients and parents desperate for treatment options, instead, Right-To-Try laws passed by a number of
- [UK Government focus on strengthening clinical research amidst unique challenges of Brexit](https://www.acrohealth.org/2018/11/28/uk-government-focus-on-strengthening-clinical-research-amidst-unique-challenges-of-brexit/) - The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts November 28, 2018 - (Washington, DC) – After three successful events with UK government officials, ACRO concludes its 2018 Clinical Research Roundtable series having brought attention to the vital role of clinical research.
- [Dr. Cynthia Verst of IQVIA Elected 2019 ACRO Chair](https://www.acrohealth.org/2019/01/30/dr-cynthia-verst-of-iqvia-elected-2019-acro-chair/) - Washington DC - The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Dr. Cynthia Verst, President of Global R&D Design and Delivery Innovation at IQVIA, as 2019 Chair. Alistair Macdonald, Chief Executive Officer of Syneos Health, was elected as Vice Chair. Dr. Verst has more than 20 years
- [ACRO expands membership with addition of three digital technology companies](https://www.acrohealth.org/2019/04/15/acro-expands-membership-with-addition-of-three-digital-technology-companies/) - The Association of Clinical Research Organizations (ACRO) is pleased to announce the expansion of its membership to include ERT, Oracle and Veeva. These new ACRO member companies, with their focus on digital technologies that enable global clinical trials, characterize the ongoing innovation and evolution of contemporary clinical research. ACRO now has 12 member companies.
- [ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice](https://www.acrohealth.org/2019/05/16/acro-offers-unique-insights-on-risk-based-monitoring-of-clinical-trials-calls-for-adoption-of-rbm-as-a-best-practice/) - Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.
- [ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic](https://www.acrohealth.org/2020/05/06/acro-members-heed-the-uk-governments-call-for-volunteers-in-response-to-the-covid-19-pandemic/) - May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research and technology organizations have volunteered to support United Kingdom government COVID-19 testing centres. These clinically-qualified volunteers will work on-site to administer throat and nasal swab tests and assist with centre operations. Volunteer participation
- [A Catalyst for Innovation, Urgency for Now, Momentum for the Future](https://www.acrohealth.org/2020/10/19/a-catalyst-for-innovation-urgency-for-now-momentum-for-the-future/) - For Dr. Sy Pretorius, Parexel’s Chief Medical & Scientific Officer, COVID-19 has been a catalyst. The pandemic has accelerated innovations that make it easier for patients to participate and for sponsors to conduct research. Parexel has seen increases in decentralized trials and remote monitoring, where study designs were adapted amidst the pandemic.
- [The need for new paradigms](https://www.acrohealth.org/2020/10/21/the-need-for-new-paradigms/) - “The pandemic has changed everything about the pace of our innovation and our focus,” says Peyton Howell, EVP and Chief Commercial & Strategy Officer at Parexel. There used to be lots of caution around using real-world data and evidence, but this year has illustrated the need for new paradigms.
- [A global sense of urgency: Collaborating to advance the conduct of clinical trials](https://www.acrohealth.org/2020/10/23/a-global-sense-of-urgency-collaborating-to-advance-the-conduct-of-clinical-trials/) - “There’s a global sense of urgency,” says Jamie Macdonald, CEO of Parexel, of the collaboration between stakeholders to accelerate development. One key focus for Macdonald is the lengthy process of trials, and compressing that “dead space” to shorten timelines, improve efficiency and quality.
- [When technology may be the easy part](https://www.acrohealth.org/2020/10/26/medidata-technology-regulatory-challenges/) - In the 10 weeks following the US’ declaration of a pandemic crisis, hospital ER visits declined for conditions like heart attacks and strokes. Simultaneously, based on clinical trials in the Medidata ecosystem, new subject enrollment declined 30%. But also in that time period, ER visits related to uncontrolled high blood sugar saw less of a decline. Patients continued to seek care. Why?
- [A new fight sees new tools and new challenges](https://www.acrohealth.org/2020/11/02/oracle-new-fight-tools-and-challenges/) - A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it appeared that a bottleneck in this race could actually be the ability to enroll participants.
- [Technology solutions: Weathering a storm, helping envision a future](https://www.acrohealth.org/2020/11/16/technology-solutions-weathering-a-storm-helping-envision-a-future/) - We all had a flurry of unprecedented activity. We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden changes that impacted patients and sites around the world.
- [Are we ready for holistic, virtual access?](https://www.acrohealth.org/2020/11/18/are-we-ready-for-holistic-virtual-access/) - Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level of remote monitoring, IQVIA is considering the implications of increasing data access. Are we ready?
- [Seeing progress through the eyes of patients](https://www.acrohealth.org/2020/11/20/seeing-progress-through-the-eyes-of-patients/) - For the clinical research industry, technological tools improve trial continuity, and generate data that helps power more robust monitoring of safety and quality. They can also be a natural fit for patients. IQVIA also sees study participants liking the direct shipment of medicines, telehealth interactions and at-home visits. In the COVID era and beyond, designing more trials with these kinds of technology-enabled strategies is going to help more people by lowering barriers to participation, and speeding the development of new medicines.
- [A ‘Holy Grail Moment’ for Clinical Research](https://www.acrohealth.org/2020/11/23/a-holy-grail-moment-for-clinical-research/) - It was a familiar scenario: A rare disease area of oncology. A new drug candidate. A desire to assess efficacy as safely and quickly as possible, so that if successful, a new therapy could get approved and change lives. But this desire could have been tempered by reality: the trial was going to be challenging and slow...
- [Warping the speed of vaccine development](https://www.acrohealth.org/2020/11/30/warping-the-speed-of-vaccine-development/) - Ironically, the Pfizer-BioNTech Covid-19 vaccine program did not take “Operation Warp Speed” funding. Even more ironic is the fact that Pfizer got there first. For a global public eagerly awaiting approved products, all that really matters is that it happened. But for the clinical research and technology industry, the details of how it happened offer
- [ACRO Launches “Good Clinical Podcast”](https://www.acrohealth.org/2023/10/12/acro-launches-good-clinical-podcast/) - WASHINGTON, DC – ACRO is pleased to announce the launch of its “Good Clinical Podcast.” The podcast brings together leaders in clinical research to discuss the latest in advocacy and cutting-edge innovation. Industry experts provide insights on the current state of clinical research and the direction the industry must head to continue improving trials for
- [ACRO Announces 2023 Officers and New Member](https://www.acrohealth.org/2023/03/06/acro-announces-2023-officers-and-new-member/) - WASHINGTON, DC – Washington DC – ACRO is pleased to announce that its Board of Directors has elected Paul Kirchgraber, M.D., Executive Vice President and CEO, Early Development, Central Laboratories and Global Oncology at Labcorp, as Chair effective January 1, 2023. Henry McNamara, Senior Vice President and General Manager at Oracle Health Sciences was elected
- [ACRO Expands Decentralized Clinical Trials Toolkit with Release of Change Management Resource](https://www.acrohealth.org/2022/10/18/acro-expands-decentralized-clinical-trials-toolkit-with-release-of-change-management-resource/) - WASHINGTON, DC - Today, the Association of Clinical Research Organizations (ACRO)’s DCT Working Party releases the latest addition to its DCT Toolkit: Navigating Change During Rapid Transformation: A Question-and-Answer Resource for Decentralized Clinical Trials. Decentralized clinical trials are here to stay. The remote, digital capabilities of DCTs provide individual, patient-centered flexibilities throughout a trial, enable
- [ACRO Releases Diversity and Inclusion Principles Statement in Support of More Diverse Clinical Trials](https://www.acrohealth.org/2022/08/25/acro-releases-diversity-and-inclusion-principles-statement-in-support-of-more-diverse-clinical-trials/) - WASHINGTON, DC – This week, the Association of Clinical Research Organizations (ACRO)’s Diversity and Inclusion in Clinical Trials committee is proud to share ACRO’s Diversity, Equity, and Inclusion Principles Statement. Created collaboratively by members of the committee and ratified by the Board, the Principles Statement is comprised of four key principles and associated actions that
- [ACRO Congressional Update – ADPPA](https://www.acrohealth.org/2022/07/11/acro-congressional-update-adppa/) - With bipartisan sponsorship from Representatives Pallone (D-NJ) and McMorris Rodgers (R-WA) the American Data Privacy and Protection Act (ADPPA), which would create a comprehensive federal consumer privacy framework, was introduced on June 21, 2022. Like the GDPR in Europe, the legislation would apply to entities or persons that “collect, process, or transfer” information that identifies
- [ACRO Celebrates 20 Years](https://www.acrohealth.org/2022/04/15/acro-celebrates-20-years/) - ACRO Celebrates 20 Years! 20 years ago, contract research organizations were still relatively new players within the clinical research enterprise, and the place of clinical trial technology providers was in its infancy. Today, CROs and technology companies are key participants in drug development and leaders in the digital transformation of clinical trials. On March 16,
- [ACRO Marks 20th Anniversary – And Welcomes New Member](https://www.acrohealth.org/2022/04/01/acro-marks-20th-anniversary-and-welcomes-new-member/) - Washington, DC — On March 16, 2022, ACRO’s Board of Directors was joined by more than 125 clinical research stakeholders – including research sponsors, CROs and technology companies, regulators and policymakers, patient groups, and others – in Washington, DC to celebrate ACRO’s 20th anniversary. As 2022 ACRO Chair Jackie Kent, Chief Customer Officer at Medidata,
- [2022 Officers and New Member Announcement](https://www.acrohealth.org/2022/01/21/2022-officers-and-new-member-announcement/) - Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Jackie Kent, Chief Customer Officer at Medidata, as Chair effective January 1, 2022. Paul Kirchgraber, M.D., Chief Executive Officer at Labcorp Drug Development, was elected Vice Chair. The Board of Directors elected Cassandra Kennedy,
- [OPINION: Clinical Trials in the Spotlight: How to Solidify the Progress Made](https://www.acrohealth.org/2021/11/30/opinion-clinical-trials-in-the-spotlight-how-to-solidify-the-progress-made/) - The below is the Op-Ed authored by ACRO Executive Director, Doug Peddicord for Morning Consult on November 3, 2021. Read the full article here. Conversations about the significance of clinical trials and the development of new vaccines and drugs are no longer exclusive to high-minded academic conferences and medical journals. Instead, these discussions are happening
- [ACRO Releases Toolkit to Help Advance Decentralized Clinical Trials](https://www.acrohealth.org/2021/08/11/acro-releases-toolkit-to-help-advance-decentralized-clinical-trials/) - Today, ACRO released its DCT Toolkit, which lays out a vision for how decentralized clinical trials can be planned and executed now and in the future. When COVID-19 hit in March 2020, clinical trial participants were cut off from in-person clinical research visits. CROs and technology companies were often able to keep active clinical trials
- [ACRO Applauds Release of Cures 2.0 Draft Legislation](https://www.acrohealth.org/2021/06/23/acro-applauds-release-of-cures-2-0-draft-legislation/) - Washington, DC — The Association of Clinical Research Organizations (ACRO) congratulates Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) on the release of the Cures 2.0 discussion draft, an update to the landmark 21st Century Cures Act. The Cures Act took significant steps to modernize the clinical trial ecosystem, and ACRO welcomes this effort to
- [ACRO Releases New Report on the Past, Present, and Future of Risk-Based Monitoring](https://www.acrohealth.org/2021/05/04/acro-releases-new-report-on-the-past-present-and-future-of-risk-based-monitoring/) - Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand implementation across the industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey of RBM implementation across 6,513 clinical trials that were ongoing in 2019 and compiled
- [2021 Officers and New Member Announcement](https://www.acrohealth.org/2020/12/17/2021-officers-and-new-member-announcement/) - Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Steve Cutler, Chief Executive Officer of ICON, as Chair effective January 1, 2021. Jackie Kent, Executive Vice President and Head of Product at Medidata Solutions, was elected Vice Chair. The Board of Directors also
- [Sharpening the pencil: Rethinking trial design with the patient at the center](https://www.acrohealth.org/2020/10/15/sharpening-the-pencil-rethinking-trial-design-with-the-patient-at-the-center-2/) - New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a clinical research site, where they are administered to a study participant. But what happens when a pandemic strikes and patients can’t access their trial site? “When COVID hit, everything kind of stopped for
- [Patient engagement, thinking ahead and how the clinical research industry helps solve global problems: A conversation with Alistair Macdonald – Part 2](https://www.acrohealth.org/2020/10/09/patient-engagement-thinking-ahead-and-how-the-clinical-research-industry-helps-solve-global-problems-a-conversation-with-alistair-macdonald-part-2/) - In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In Part 2, we look at patient engagement and the conduct of clinical research, shifting the conduct of clinical trials for patients and the industry, working with regulators and the future of industry collaboration.
- [Clinical Research in the COVID Era: Learning Lessons, Saving Lives](https://www.acrohealth.org/2020/09/29/clinical-research-in-the-covid-era-learning-lessons-saving-lives/) - Doug Peddicord, ACRO’s Executive Director, introduces the series and sheds light on the importance of CROs and technology companies in spearheading clinical innovation through COVID-19 and beyond.
- [COVID, the role of digital, and the future of clinical research: A conversation with Alistair Macdonald – Part 1](https://www.acrohealth.org/2020/09/29/covid-the-role-of-digital-and-the-future-of-clinical-research-a-conversation-with-alistair-macdonald-part-1-15/) - In August 2020, Syneos Health CEO and ACRO Board Chair Alistair Macdonald reflected on the COVID-19 crisis to date. This conversation has been edited lightly for clarity.
- [New ACRO Report Introduces Quality-by-Design, Risk-Based Framework for Decentralizing Clinical Trials](https://www.acrohealth.org/2020/09/01/new-acro-report-introduces-quality-by-design-risk-based-framework-for-decentralizing-clinical-trials/) - September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This approach can place a time or cost burden on patients, creating an inconvenience that can limit enrollment speed or trial completion. To transcend these limitations, clinical researchers are continually identifying ways to leverage
- [2020 Officers and New Member Announcement](https://www.acrohealth.org/2019/12/17/2020-officers-and-new-member-announcement/) - Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair Macdonald, Chief Executive Officer of Syneos Health, as 2020 Chair. Steve Cutler, Chief Executive Officer of ICON, was elected Vice Chair. The Board of Directors also elected Jason Meggs, Chief Financial Officer at
- [ACRO hosts Congressional Briefing on clinical research advancements](https://www.acrohealth.org/2019/10/24/acro-hosts-congressional-briefing-on-clinical-research-advancements/) - On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development Caucus, a panel of clinical research experts and leaders was able to educate congressional offices on the advancements clinical research and technology companies are making in drug development. The conversation focused on how
- [Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials](https://www.acrohealth.org/2019/08/16/advancing-the-adoption-of-risk-based-monitoring-strategies-in-clinical-trials/) - On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.
- [ACRO testifies before IRS and Treasury Department on proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation](https://www.acrohealth.org/2019/03/29/acro-testifies-before-irs-and-treasury-department-on-proposed-base-erosion-and-anti-abuse-tax-beat-regulation/) - On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department regarding the recently released Base Erosion and Anti-Abuse Tax (BEAT) proposed regulation. Representing ACRO at the hearing were Candice Whitehurst, Associate Director of Tax at Syneos Health, and John Benoit, Corporate Vice President,
- [EU efforts turn towards digital for 2019](https://www.acrohealth.org/2019/02/27/eu-efforts-turn-towards-digital-for-2019/) - 2018 was a busy and productive year for ACRO’s European Scientific & Regulatory Committee, which meets quarterly in London. While the Committee focused largely on the continuing implementation of the EU Clinical Trial Regulation, there were also opportunities to engage with regulators on other topics ranging from European regulatory strategy to Advanced Therapies to the urgent challenges of Brexit.
- [ACRO members talk UK competitiveness and enabling post-Brexit success](https://www.acrohealth.org/2018/07/19/acro-members-talk-uk-competitiveness-and-enabling-post-brexit-success/) - What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto extremely rare incidents from a decade ago, what can be done to raise the profile of clinical trials and elevate positive stories? As the industry looks to adapt and thrive amidst political and
- [Who’s in and who’s out? ACRO talks Inclusion-Exclusion Criteria](https://www.acrohealth.org/2018/05/29/fda-inclusion-exclusion-criteria/) - ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related, moving parts and large, global clinical research organizations (CROs) mirror that complexity. When we examine questions of trial participation – criteria for inclusion and exclusion – CROs approach the issue from a variety
- [Peddicord Elected to CDISC Board](https://www.acrohealth.org/2012/12/12/peddicord-elected-to-cdisc-board/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Executive Director Elected To Clinical Data Standards Group Board DECEMBER 12, 2012 – WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) today announced Executive Director Doug Peddicord, Ph.D. was named to the Board of Directors for the Clinical Data Interchange Standards Consortium (CDISC). CDISC is a global non-profit organization that
- [ACRO Statement Regarding Access to Medicine Index](https://www.acrohealth.org/2012/11/28/acro-statement-regarding-access-to-medicine-index/) - ACRO Statement Regarding Access to Medicine Index Several media outlets have reported on the Access to Medicines Index and the report’s assertions regarding clinical research organizations. Unfortunately, none of these media attempted to contact ACRO or its members for comment. The Access to Medicines Index fundamentally misrepresents the relationship between research sponsors and clinical research organizations (CROs)
- [Television's Assault on Medical Research](https://www.acrohealth.org/2012/09/27/televisions-assault-on-medical-research/) - Television's Assault on Medical Research ACRO Executive Director took on the television industry's recent assault on medical research in this Huffington Post blog from September 25, 2012. For some reason, there is a newfound fascination with clinical trials among TV producers. Of course they've sensationalized clinical trials by playing to the lowest common denominator, and
- [ACRO Comments on PCORI Methodology](https://www.acrohealth.org/2012/09/14/acro-comments-on-pcori-methodology/) - September 14, 2012 Sherine Gabriel, MD, MSc Chair Methodology Committee Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Dr. Joe Selby Executive Director Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Dear Drs. Gabriel and Selby: The Association of Clinical Research Organizations (ACRO)
- [Physician Payment Sunshine Statement](https://www.acrohealth.org/2012/09/13/physician-payment-sunshine-statement/) - Statement for the Record Special Committee on Aging United States Senate Roundtable on Implementation of the Physician Payments Sunshine Act September 12, 2012 Chairman Kohl, Ranking Member Corker, members of the Committee, thank you for extending an invitation to the Association of Clinical Research Organizations (ACRO) and providing us an opportunity to share our
- [New ACRO Video Series Debuts](https://www.acrohealth.org/2012/08/14/new-acro-video-series-debuts/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org Leaders of CRO Industry Featured In New ACRO Video Series AUGUST 9, 2012, WASHINGTON, DC - The Association of Clinical Research Organizations (ACRO) today announced the release of a new video series on itsYouTube Channel. The videos were selected from an executive roundtable session held during this year’s Annual Meeting
- [Statement on European Clinical Trial Rules](https://www.acrohealth.org/2012/07/18/statement-on-european-clinical-trial-rules/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Statement on European Commission’s Proposal for Clinical Trials Regulation July 18, 2012 - WASHINGTON, DC – Today, Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO), made the following statement regarding the European Commission’s proposal for the regulation of clinical trials. “The Association of Clinical Research Organizations
- [No Regional Differences in Quality of Clinical Trial Data](https://www.acrohealth.org/2012/07/12/no-regional-differences-in-quality-of-clinical-trial-data/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org No Differences in Quality of Clinical Trial Data Across Regions, Reports Drug Information Journal July 12, 2012 - WASHINGTON, DC – “A formal statistical evaluation indicates no significant differences in data quality for clinical trials conducted in developing regions relative to mature regions,” says an article published in the July 2012 issue of the Drug
- [No Quality Differences in Global Trials](https://www.acrohealth.org/2012/07/10/no-quality-differences-in-global-trials/) - An article in the July issue of Drug Information Journal that analyzed 26 large-scale Phase II/III multi-regional clinical trials enrolling nearly 64,000 participants concluded “a formal statistical evaluation indicates no significant differences in data quality for clinical trials conducted in developing regions relative to mature regions.” Download PDF for full article. Download as PDF
- [ACRO Pushes Global Trials Language in PDUFA](https://www.acrohealth.org/2012/06/06/acro-pushes-global-trials-language-in-pdufa/) - June 5, 2012 Dear Chairman Harkin, Chairman Upton, Ranking Member Enzi and Ranking Member Waxman: The Association of Clinical Research Organizations (ACRO) commends you and thanks you for your thoughtful and timely consideration of the reauthorization of the Prescription Drug User Fee Act (PDUFA). ACRO represents the world’s leading clinical research organizations and each year
- [ACRO Takes To Video To Advise FDA on Innovation](https://www.acrohealth.org/2012/05/16/acro-takes-to-video-to-advise-fda-on-innovation/) - Contact: Leslie Irvine 202.464.9340 lirvine@www.acrohealth.org ACRO Takes To Video To Advise FDA on Innovation May 16, 2012 - WASHINGTON, DC – Building on its recent testimony to the FDA on modernizing clinical trials, the Association of Clinical Research Organizations(ACRO) has released a new video exhorting the FDA to demonstrate “bold leadership” to help make the drug development process less expensive, faster
- [ACRO Testifies to FDA on Clinical Trial Modernization](https://www.acrohealth.org/2012/04/20/acro-testifies-to-fda-on-clinical-trial-modernization/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Testifies Before FDA on Clinical Trial Modernization Calls for Chief Innovation Officer April 23, 2012 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) today provided the FDA with a number of suggestions to improve the drug development process, highlighted by a call to appoint a Chief Innovation Officer within
- [ACRO Launches YouTube Channel](https://www.acrohealth.org/2012/03/19/acro-launches-youtube-channel/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Launches YouTube Channel To Educate About Clinical Trials and CROs March 19, 2012 - WASHINGTON, DC – In an effort to educate the public, media and policymakers about clinical trials and the growing role of clinical research organizations in the drug development process, the Association of Clinical Research Organizations (ACRO) has launched
- [ACRO Comment on Dateline NBC](https://www.acrohealth.org/2012/03/02/acro-comment-on-dateline-nbc/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org Dateline NBC Report on Overseas Medical Research Strengthens ACRO Argument for Increased FDA Funding March 2, 2012 - WASHINGTON, DC - Association of Clinical Research Organizations (ACRO) Vice President of Public Affairs John Lewis released the following statement in anticipation of Sunday’s Dateline NBC report on global clinical trials: “The American public should have
- [ACRO Comments on Physician Payment Sunshine](https://www.acrohealth.org/2012/02/17/acro-comments-on-physician-payment-sunshine/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Implores CMS To Limit Research Definition For Sunshine Reporting February 17, 2012 - WASHINGTON, D.C. – Expressing concerns that many physicians will be discouraged from conducting medical research because of cumbersome reporting requirements and potential mischaracterizations of their income, the Association of Clinical Research Organizations (ACRO) is urging the Centers
- [ACRO Comments on PCORI Research Agenda](https://www.acrohealth.org/2012/02/17/acro-comments-on-pcori-research-agenda/) - February 17, 2012 Patient-Centered Outcomes Research Institute Public Comments 1701 Pennsylvania Ave. NW Suite 300 Washington, DC 20006 Re: Draft National Priorities for Research and Research Agenda, Version I The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations (CROs). Our member companies provide a wide range of specialized services across the
- [ACRO Comments on Washington Post Article](https://www.acrohealth.org/2012/01/03/acro-comments-on-washington-post-article/) - The Association of Clinical Research Organizations, whose members conduct an estimated two-thirds of the clinical trials in India, strongly disagrees with the premises and conclusions of “India’s drug trials fuel consent controversy”. Unfortunately, Ms. Lakshmi did not bother to contact us for comment. Ms. Lakshmi states that “(a)cross India, 1,700 people who participated in clinical drug
- [Jeff McMullen Elected 2012 ACRO Chairman](https://www.acrohealth.org/2011/12/01/jeff-mcmullen-elected-2012-acro-chairman/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org PharmaNet/i3 CEO Jeff McMullen Elected 2012 ACRO Chairman December 1, 2011 - WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO) today announced its Board of Directors has elected Jeffrey P. McMullen as its 2012 Chairman. Mr. McMullen is President and Chief Executive Officer of PharmaNet/i3, the clinical segment of inVentiv Health, and
- [ACRO Endorses Foreign Earnings Reinvestment Act](https://www.acrohealth.org/2011/10/06/acro-endorses-foreign-earnings-reinvestment-act/) - Contact: John Lewis 202.464.9340 jlewis@www.acrohealth.org ACRO Endorses Foreign Earnings Reinvestment Act October 6, 2011 - WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO) announced its support to the Foreign Earnings Reinvestment Act introduced today in the U.S. Senate by Senators Kay Hagan (D-NC) and John McCain (R-AZ). This bipartisan legislation primes the pump for American
- [Member Survey Shows CRO Industry Growth](https://www.acrohealth.org/2011/10/03/member-survey-shows-cro-industry-growth/) - Contact: John Lewis (O) 202.464.9340 (M) 202.285.5726 jlewis@www.acrohealth.org New ACRO Member Survey Shows Growth of CRO Industry Captures Range and Scope of Drug Development Services October 3, 2011 - WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the global leaders in clinical outsourcing, today reported that its members have expanded their payroll
- [ACRO Recognizes World Heart Day](https://www.acrohealth.org/2011/09/29/acro-recognizes-world-heart-day/) - Contact: John Lewis (O) 202.464.9340 (M) 202.285.5726 jlewis@www.acrohealth.org ACRO Recognizes World Heart Day With Focus on Clinical Research September 29, 2011 - WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the global leaders in clinical outsourcing, today released the following statement in recognition of World Heart Day. “Last year, ACRO member companies conducted
- [ACRO Executive Director Speaking at DIA](https://www.acrohealth.org/2011/06/14/acro-executive-director-speaking-at-dia/) - Contact: John Lewis (O) 202.464.9340 (M) 202.285.5726 jlewis@www.acrohealth.org ACRO Executive Director Doug Peddicord Moderating Panel On HIPAA and Comparative Effectiveness Research at DIA June 14, 2011 - WASHINGTON, D.C. – Douglas Peddicord, Ph.D., Executive Director of the Association of Clinical Research Organizations will be moderating a session at the 2011 Drug Information Association Annual Meeting titled : “Encouraging Comparative
- [Global Clinical Trials: Setting the Record Straight](https://www.acrohealth.org/2011/04/26/global-clinical-trials-setting-the-record-straight/) - By Doug Peddicord ACRO Executive Director Posted: 04/25/11 07:38 PM ET by the Huffington Post Increasingly, the global infrastructure supporting the development of new drugs, biologics and medical devices resides within clinical research organizations. In fact, while "big pharma" has been shedding research facilities and staff, members of the Association of Clinical Research Organizations (ACRO)
- [ACRO Files Amicus Brief in Sorrell v. IMS Health](https://www.acrohealth.org/2011/04/04/acro-files-amicus-brief-in-sorrell-v-ims-health/) - Contact: John Lewis (O) 202.464.2310 (M) 202.285.5726 john.lewis@www.acrohealth.org ACRO Files Brief with U.S. Supreme Court to Support Availability Of Prescription Data for Use in Clinical and Medical Research April 1, 2011 - WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the global clinical outsourcing industry to regulators, biopharmaceutical clients, policy makers
- [Doug Peddicord Discusses CER in Health Affairs](https://www.acrohealth.org/2010/11/02/doug-peddicord-discusses-cer-in-health-affairs/) - Media Contact: John Lewis 202.464.2310 john.lewis@www.acrohealth.org ACRO EXECUTIVE DIRECTOR DISCUSSES DATA PRIVACY AND CER IN HEALTH AFFAIRS ARTICLE Washington, DC, November 2, 2010 –– Doug Peddicord, Ph.D., Executive Director of the Association of Clinical Research Organizations, is the lead author of “A Proposal To Protect Privacy Of Health Information While Accelerating Comparative Effectiveness Research” appearing in the
- [ACRO Comments on GAO's Report on FDA's Overseas Offices](https://www.acrohealth.org/2010/10/27/acro-comments-on-gaos-report-on-fdas-overseas-offices/) - Media Contact: John Lewis 202.464.2310 john.lewis@www.acrohealth.org ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS CALLS FOR ADDITIONAL FUNDING FOR FDA’S OVERSEAS OFFICES Washington, DC, October 28, 2010 –– The Association of Clinical Research Organizations, which represents the global CRO industry, issued the following statement in response to the Government Accountability Office’s report on the Food and Drug Administration’s Overseas Offices.
- [ACRO Comments on Privacy Rule in CTA](https://www.acrohealth.org/2010/07/30/acro-comments-on-privacy-rule-in-cta/) - July 30, 2010 Download as PDF
- [ACRO Pleased that Proposed HHS Privacy Rule Addresses Concerns of Health Researchers](https://www.acrohealth.org/2010/07/13/acro-pleased-that-proposed-hhs-privacy-rule-addresses-concerns-of-health-researchers/) - FOR IMMEDIATE RELEASE Media Contact: John Lewis 202.464.2310 (office) 202.285.5726 (mobile) john.lewis@www.acrohealth.org ACRO Pleased that Proposed HHS Privacy Rule Addresses Concerns of Health Researchers Washington, DC, July 13, 2010 –– The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding a proposed privacy rule from the Department of Health and
- [ACRO Announces Agreement with University of Florida College of Pharmacy for Reduced Tuition Benefit](https://www.acrohealth.org/2010/06/23/acro-announces-agreement-with-university-of-florida-college-of-pharmacy-for-reduced-tuition-benefit/) - Contact: John Lewis 202.464.2310 (office) 202.285.5726 (mobile) john.lewis@www.acrohealth.org ACRO Announces Agreement with University of Florida College of Pharmacy for Reduced Tuition Benefit Employees of ACRO Member Companies Eligible June 23, 2010 – Washington, DC –The Association of Clinical Research Organizations (ACRO), which represents the CRO industry globally, today announced an agreement with the University of Florida College of Pharmacy(UFCoP) to
- [ACRO Responds to HHS Report on FDA Inspection of Foreign Clinical Trials](https://www.acrohealth.org/2010/06/22/acro-responds-to-hhs-report-on-fda-inspection-of-foreign-clinical-trials/) - Media Contact: John Lewis 202.464.2310 (office) 202.285.5726 (mobile) john.lewis@www.acrohealth.org ACRO Responds to HHS Report on FDA Inspection of Foreign Clinical Trials Reiterates Need to Increase Funding for FDA Office of International Programs Washington, DC, June 22, 2010 – The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding a
- [ACRO Announces Findings from Groundbreaking Survey Exploring Barriers To Physician Participation in Clinical Research](https://www.acrohealth.org/2010/06/14/acro-announces-findings-from-groundbreaking-survey-exploring-barriers-to-physician-participation-in-clinical-research/) - Media Contact: Christina Plourde 202/587-2596 cplourde@spectrumscience.com ACRO Announces Findings from Groundbreaking Survey Exploring Barriers To Physician Participation in Clinical Research Results Highlighted at Annual Drug Information Association Meeting in Washington, DC Washington, DC, June 14, 2010 –Today, the Association of Clinical Research Organizations (ACRO) unveiled findings from a groundbreaking survey exploring the decline in physician participation in
- [ACRO To Unveil Findings From Physician Investigator Survey and Present on Globalization of Clinical Research at Annual DIA Meeting](https://www.acrohealth.org/2010/06/02/acro-to-unveil-findings-from-physician-investigator-survey-and-present-on-globalization-of-clinical-research-at-annual-dia-meeting/) - *ACRO Leadership Available for Interviews During Conference* Who: Executive Director, Doug Peddicord, Ph.D., and Vice President of Public Affairs, John Lewis, from the Association of Clinical Research Organizations (ACRO), will present on global clinical research issues and reveal findings from groundbreaking survey research evaluating physician participation in clinical research during the 46th Drug Information Association’s (DIA) Annual Meetingon June 13-17,
- [ACRO Applauds Appointment of Dr. Harold Varmus to Lead NCI](https://www.acrohealth.org/2010/05/18/acro-applauds-appointment-of-dr-harold-varmus-to-lead-nci/) - Contact: John Lewis 202.464.2310 (office) 202.285.5726 (mobile) john.lewis@www.acrohealth.org ACRO Applauds Appointment of Dr. Harold Varmus to Lead NCI Reform of Clinical Trials Process Should Be Top Priority May 18, 2010 – Washington, DC – The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding the appointment of Nobel Prize winning
- [Chiltern Newest Member of ACRO](https://www.acrohealth.org/2010/05/06/chiltern-newest-member-of-acro/) - Contact: John Lewis 202.464.2310 (office) 202.285.5726 (mobile) john.lewis@www.acrohealth.org Chiltern Joins Association of Clinical Research Organizations Becoming Second European-based ACRO Member May 6, 2010 – Washington, DC – The Association of Clinical Research Organizations, which represents the CRO industry globally, is pleased to announce that Chiltern, headquartered in Berkshire, United Kingdom, has joined ACRO and that Glenn
- [ACRO Funds Global Healthcare Innovation Management Center](https://www.acrohealth.org/2010/04/19/acro-funds-global-healthcare-innovation-management-center/) - ACRO Funds Global Healthcare Innovation Management Center Centerwatch, April 2010 ACRO featured for their contribution to the Fordham University Global Healthcare Innovation Management Center.
- [ACRO Funding Global Healthcare Innovation Management Center At Fordham University Schools of Business](https://www.acrohealth.org/2010/04/12/acro-funding-global-healthcare-innovation-management-center-at-fordham-university-schools-of-business/) - Contact: John Lewis 202.464.2310 john.lewis@www.acrohealth.org ACRO Funding Global Healthcare Innovation Management Center At Fordham University Schools of Business April 12, 2010 – Washington, DC – As part of an effort to lead the discussion about evolving drug development models, the Association of Clinical Research Organizations announced today that it is among the founding members of
- [Joe Herring of Covance Elected 2011 ACRO Chair](https://www.acrohealth.org/2010/03/18/joe-herring-of-covance-elected-2011-acro-chair/) - Joe Herring of Covance Elected 2011 ACRO Chair February 7, 2011- WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the global clinicaloutsourcing industry to regulators, biopharmaceutical clients, policy makersand the public, today announced its Board of Directors has elected Joe Herring,Chairman and Chief Executive Officer of Covance Inc., as its 2011
- [Going Global - Global Development](https://www.acrohealth.org/2010/03/01/going-global-global-development/) - Going Global - Global Development PharmaVOICE, March 2009 ACRO Executive Director Doug Peddicord was included in a feature on the globalization of drug development. Dr. Peddicord discussed the global nature of CROs and the need to represent the industry on a global basis.
- [Sharbaugh of PPD Elected ACRO Chair; Herring of Covance Chair-Elect](https://www.acrohealth.org/2010/01/07/sharbaugh-of-ppd-elected-acro-chair-herring-of-covance-chair-elect/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 Sharbaugh of PPD Elected ACRO Chair; Herring of Covance Chair-Elect Date of Release: 7 January 2010 Sharbaugh of PPD Elected 2010 ACRO Chair Herring of Covance to Serve as Chair-Elect ICON Takes Seat on Board; Clinical Research Management Joins as Associate January 7, 2010 - WASHINGTON, D.C.
- [ACRO Calls on Congress to Require Clinical Testing](https://www.acrohealth.org/2009/10/14/acro-calls-on-congress-to-require-clinical-testing/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Calls on Congress to Require Clinical Testing Date of Release: 14 October 2009 ACRO Calls on Congress to Require Clinical Testing In Biosimilars Legislation to Ensure Patient Welfare, Efficacy WASHINGTON, D.C., October 14, 2009 –- The Association of Clinical Research Organizations has called on Congress to
- [Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels](https://www.acrohealth.org/2009/07/21/clinical-research-safety-and-ethical-standards-in-developing-world-up-to-u-s-levels/) - FOR IMMEDIATE RELEASE CONTACT: Aaron Cohen aaron.cohen@mslworldwide.com 202.261.2869 Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels Date of Release: 21 July 2009 CLINICAL RESEARCH SAFETY AND ETHICAL STANDARDS IN DEVELOPING WORLD UP TO U.S. LEVELS, REPORT SAYS Clinical Research Organizations urge full funding for FDA to conduct foreign safety inspections
- [Media Advisory - Release of Globalization Report](https://www.acrohealth.org/2009/07/15/media-advisory-release-of-globalization-report/) - FOR IMMEDIATE RELEASE CONTACT: Aaron Cohen aaron.cohen@mslworlwide.com 202.261.2869 Media Advisory - Release of Globalization Report * * * Media Advisory * * * CLINICAL RESEARCH SAFETY AND ETHICAL STANDARDS IN DEVELOPING WORLD UP TO U.S. STANDARDS, REPORT SAYS WHAT: A major report by the Association of Clinical Research Organizations (ACRO) concludes that clinical trials conducted in
- [This time, White House Receives Kudos for Participation](https://www.acrohealth.org/2009/07/07/this-time-white-house-receives-kudos-for-participation/) - This time, White House Receives Kudos for Participation National Journal/NextGov, July 2009 Article about the process used by the Federal Coordinating Council to solicit input into CER priorities, quoting ACRO VP John Lewis.
- [Interview with Doug Peddicord](https://www.acrohealth.org/2009/07/07/interview-with-doug-peddicord/) - Interview with Doug Peddicord R&D Directions, June 2009 In this interview, ACRO Executive Director Doug Peddicord covers CER, globalization, HIT and more
- [The Hot Jobs Where Pay is Rising in the Recession](https://www.acrohealth.org/2009/07/01/the-hot-jobs-where-pay-is-rising-in-the-recession/) - The Hot Jobs Where Pay is Rising in the Recession Forbes, July 2009 ACRO quoted on positive job prospects for Medical/Clinical Lab Technologists and growth of outsourcing.
- [ACRO Response to "Helping Science, Making Money"](https://www.acrohealth.org/2009/07/01/acro-response-to-helping-science-making-money/) - ACRO Response to "Helping Science, Making Money" Wall Street Journal, July 2009 ACRO's response to book review by Dr. Scott Gottlieb of AEI.
- [ACRO Supports Patient-Centered Outcomes Research Act](https://www.acrohealth.org/2009/06/11/acro-supports-patient-centered-outcomes-research-act/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Supports Patient-Centered Outcomes Research Act ACRO Statement Supporting The Patient-Centered Outcomes Research Act of 2009 June 11, 2009– WASHINGTON, DC – The following is the statement of Doug Peddicord, PhD, Executive Director of the Association of Clinical Research Organizations (ACRO), on S. 1213 the “Patient-Centered Outcomes
- [ACRO Webinar on Privacy and R&D](https://www.acrohealth.org/2009/05/19/acro-webinar-on-privacy-and-rd/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Webinar on Privacy and R&D ACRO and ExL Pharma Co-sponsoring Webinar on How Privacy Provisions of Stimulus Bill will Effect Biopharma R&D May 19, 2009– WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) is pleased to partner with ExL Pharma to produce a webinar:
- [ACRO Comments on Naming of FDA Commissioner and Deputy](https://www.acrohealth.org/2009/03/16/acro-comments-on-naming-of-fda-commissioner-and-deputy/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Comments on Naming of FDA Commissioner and Deputy Date of Release: 16 March 2009 Remarks should be attributed to ACRO Executive Director Doug Peddicord, PhD. March 16, 2008 – WASHINGTON, DC - Under Peggy Hamburg’s leadership we expect the FDA to refocus on science and research
- [ACRO Presents Before Japan CRO Association](https://www.acrohealth.org/2009/02/26/acro-presents-before-japan-cro-association/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Presents Before Japan CRO Association WASHINGTON, D.C. and TOKYO – As the voice of the global clinical outsourcing industry, the Association of Clinical Research Organizations (ACRO) had the honor of presenting before the Japan CRO Association’s 15th Commemorative Symposium February 26th, 2009 in Tokyo. ACRO Chair
- [ACRO Comments on NEJM Article on Globalization of Clinical Research](https://www.acrohealth.org/2009/02/20/acro-comments-on-nejm-article-on-globalization-of-clinical-research/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.464.2310 ACRO Comments on NEJM Article on Globalization of Clinical Research The Association of Clinical Research Organizations (ACRO), which represents the clinical outsourcing industry to regulators, biopharmaceutical clients, policy makers and the public in the U.S. and worldwide, issued the following comment on the article “Ethical and Scientific
- [Dr. Derek Winstanly of Quintiles to Serve as 2009 ACRO Chair](https://www.acrohealth.org/2009/01/13/dr-derek-winstanly-of-quintiles-to-serve-as-2009-acro-chair/) - FOR IMMEDIATE RELEASE CONTACT: John Lewis john.lewis@www.acrohealth.org 202.285.5726 Dr. Derek Winstanly of Quintiles to Serve as 2009 ACRO Chair Date of Release: 13 January 2009 WASHINGTON, D.C. – The Association of Clinical Research Organizations (ACRO), which represents the clinical outsourcing industry to regulators, biopharmaceutical clients, policy makers and the public in the U.S. and worldwide,

## Pages

- [ACRO Health](https://www.acrohealth.org/) - ACRO advocates as the collective voice of innovative clinical research and technology organizations.
- [ACRO 2026 Global Clinical Trials 
Regulatory Summit](https://www.acrohealth.org/2026-global-clinical-trials-regulatory-summit/) - September 22-23, 2026 About the event ACRO, an association representing the world’s leading clinical research and technology organizations, invites you to participate in a global summit focused on the most pressing regulatory issues and opportunities impacting clinical trials and innovation. This summit will convene senior regulators and senior industry leaders from around the globe for frank,
- [Patient Access to Clinical Trials (PACT)](https://www.acrohealth.org/initiatives-hub/diversity-equity-and-inclusion-in-clinical-trials/) - ACRO’s Patient Access to Clinical Trials (PACT) Committee was formed in 2020 as a part of ACRO’s ongoing efforts to advance clinical research access and representation. Site Resource Grants Program In 2024, ACRO announced its Site Resource Grants Program, a platform designed to incubate innovative strategies for improving representative enrollment in clinical research. Seven community
- [Current Members](https://www.acrohealth.org/acro-members/) - Our members are global clinical research and technology companies.
- [ACRO's Initiatives](https://www.acrohealth.org/initiatives-hub/) - ACRO’s initiatives bring together subject matter experts from each of ACRO’s member companies to work collaboratively on the topics most impacting clinical research today. Read more about ACRO’s top initiatives, including AI/ML in drug development, risk-based quality management, and clinical trial access and representation: Artificial Intelligence & Machine LearningACRO’s AI/ML Committee brings together member company
- [Risk-Based Quality Management](https://www.acrohealth.org/initiatives-hub/risk-based-quality-management/) - Risk-based quality management is an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. Thought Leadership on RBQM Since 2019, ACRO’s RBQM Working Group has administered a yearly survey focused on industry adoption of risk-based monitoring (RBM)
- [RBQM Summary Report](https://www.acrohealth.org/rbqm-summary-report/) - ACRO conducted its seventh consecutive landscape survey of member company CROs. The following report highlights ACRO’s key findings from data reported for 2025.
- [Our Mission](https://www.acrohealth.org/our-mission/) - Hear from Sandy Kennedy, ACRO's 2025 Chair. Advancing Clinical Research, Together ACRO members: Advance clinical outsourcing to improve the quality, efficiency and safety of biomedical research Conduct thousands of clinical trials around the world while ensuring the safety of research participants Strengthen public understanding and confidence in clinical research, highlighting member company expertise in all
- [ACRO State of the Industry Report](https://www.acrohealth.org/acro-state-of-industry-report/) - ACRO's State of the Industry Report Data collected from 15 member companies reveals the industry's impact on drug development. Published: March 2026 with data collected for 2025 Trials and Participants Revenue & Companies AI Adoption FDA Vaccines Additional Metrics Overview & Methodology In early 2026, ACRO conducted an online survey of its member companies evaluating their
- [2024 Member Demographics Survey](https://www.acrohealth.org/acro-member-demographics-survey/) - ACRO 2024 Member Demographics Survey A demographics survey of ACRO member companies demonstrating the impact of the industry on drug development. Overview Trials and Participants Revenue and Companies Represented AI Adoption Vaccines Statistics Overview & Methodology In early 2025, ACRO conducted an online survey of its member companies. The survey was held among 15 ACRO member companies
- [ACRO's Good Clinical Podcast](https://www.acrohealth.org/good-clinical-podcast/) - Listen to today’s industry leaders share their insights on hot topics and trends in the clinical research ecosystem. Subscribe on Spotify, Apple Podcasts, and YouTube. From AI and other cutting-edge technology to regulatory topics that impact clinical trials around the world, ACRO’s Good Clinical Podcast dives into topics vital to driving innovation in clinical research.
- [ACRO NEWS IN YOUR INBOX](https://www.acrohealth.org/subscribe/) - The Association of Clinical Research Organizations (ACRO) is a hub for clinical research and technology companies around the world. We send periodic emails to bring you updates on our work, the latest ACRO news, the Good Clinical Podcast, and our progress in advancing the global clinical research industry.
- [ACRO Membership](https://www.acrohealth.org/acromembership/) - A Network of Collaboration and Engagement ACRO is a hub for peer-to-peer networking and our working groups facilitate thought leadership, industry-wide discussion and action on key issues. We build relationships with regulators from the FDA, EMA and other agencies, providing input and subject matter expertise on a variety of regulatory issues. ACRO links members with
- [Global Data Protection & Privacy](https://www.acrohealth.org/initiatives-hub/global-data-protection-privacy/) - Preparing for an increasingly data-linked future. ACRO’s GDPP Committee connects representatives of member companies with a range of stakeholders on important issues of privacy, data protection and data security. The committee’s efforts focus on how the industry interprets regulations and guidances and prepares for new legislation. Committee members provide input into policy deliberations and help
- [Informed Content Hub (ICH)](https://www.acrohealth.org/informed-content-hub/) - Featured Filter Posts: Sort By:
- [Advocacy](https://www.acrohealth.org/advocacy-hub/) - ACRO works with legislators and regulators across the U.S. and Europe to ensure a positive regulatory environment that supports high-quality, safe and ethical clinical research. Learn more about ACRO’s advocacy efforts spanning both the U.S. and Europe. U.S. Legislation and RegulationView Resources European Legislation and RegulationView Resources
- [Sign Up for Updates](https://www.acrohealth.org/sign-up-for-updates/) - ACRO is a hub for clinical research and technology companies around the world. In our newsletter, we bring you updates on our work and the impact that we are having in advancing the global clinical research industry. Read Previous Newsletters May 27, 2025Good Clinical Podcast - Season 3, Episode 6: Strategic Uses of AI in
- [Newsroom](https://www.acrohealth.org/news/) - The latest news and press releases from ACRO. Filter Posts:
- [Sustainability in Clinical Trials](https://www.acrohealth.org/initiatives-hub/sustainability-in-clinical-trials/) - The Sustainability Committee brings together ACRO member company representatives, including sustainability officers and other stakeholders, focused on reducing the environmental impact of clinical research and clinical trials. Thought Leadership Committee members are committed to sharing strategies, identifying key sustainability metrics, and developing best practices to advance sustainable initiatives within the industry whilst helping sponsors meet
- [Informational Security Practices in Clinical Trials](https://www.acrohealth.org/initiatives-hub/informational-security-practices-in-clinical-trials/) - The CISO Committee brings together member company Chief Information Security Officers (CISO) and others involved in information security to share threat and related security information and to educate stakeholders on acceptable information security practices. Thought Leadership The cyber threat landscape has grown significantly more complex over the past number of years, with the increased use
- [AI/ML in Drug Development](https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/) - ACRO’s AI/ML Committee brings together member company subject matter experts engaged in the development and use of AI/ML tools in the design, conduct, oversight, and analysis of clinical trials. Thought Leadership ACRO’s Artificial Intelligence/Machine Learning Committee produced the following Principles Statement in December 2023. The committee represents the industry to regulators and policymakers considering regulation
- [ACRO Forum](https://www.acrohealth.org/acro-forum/) - How ACRO members engage with our Sponsor colleagues and TransCelerate Biopharma, Inc. About the ACRO Forum The ACRO Forum was established in 2015 as a special mechanism to interact with TransCelerate BioPharma, Inc. The Forum provides an opportunity for subject matter experts (SMEs) from ACRO members to engage colleagues, provide industry input to TransCelerate workstreams and report
- [Interpreting ICH E6(R3)](https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/) - In January 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued the final version of its updated ICH E6(R3) Good Clinical Practice Guideline. ICH E6(R3) is intended to provide, “a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory
- [European Legislation & Regulation](https://www.acrohealth.org/advocacy-hub/european-legislation-regulation/) - Advancing industry interests in European legislation and regulation ACRO’s European agenda is focused on advancing policies that foster innovation and harmonization. ACRO member companies have a strong presence in the EU and UK. In 2024, ACRO members employed more than 73,000 individuals across Europe. ACRO engages with regulators and policymakers in the EU and UK
- [U.S. Legislation & Regulation](https://www.acrohealth.org/advocacy-hub/us-legislation-regulation/) - Enabling clinical research by advancing U.S. legislation and regulation ACRO supports a strong, robust FDA with expanded resources to ensure better control over the quality, safety, and efficacy of clinical trials and drug development in the United States. ACRO’s U.S. agenda is focused on promoting policies that foster innovation. ACRO engages with – and provides industry
- [ACRO Announces Recipients of Diversity and Inclusion Site Resource Grants](https://www.acrohealth.org/recipients-announced-acros-diversity-and-inclusion-site-resource-grants-program/) - ACRO’s Diversity and Inclusion in Clinical Trials Committee announced the seven community sites that have been selected as recipients of ACRO’s Diversity and Inclusion Site Resource Grants. The ACRO D&I Site Resource Grants Program is designed to support a 12-month pilot project, serving as a platform to incubate innovative strategies for improving diverse enrollment in
- [Decentralized Clinical Trials](https://www.acrohealth.org/initiatives-hub/decentralized-trials/) - ACRO members work to examine the barriers to adoption of DCTs and create quality-based principles and tools to facilitate implementation of decentralized clinical trials. Thought Leadership on DCTs ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT
- [ACRO's Diversity and Inclusion Site Resource Grants Program](https://www.acrohealth.org/di-grants/) - Mission In Spring 2024, ACRO invited submissions for its new Diversity and Inclusion Site Resource Grants Program. The ACRO D&I Site Resource Grants Program aims to help sites interested in improving trial inclusivity—who have the potential to contribute to diverse enrollment—acquire the resources and skills that will get them selected for studies and improve the
- [Join Us at the DIA 2024 Global Annual Meeting](https://www.acrohealth.org/join-us-at-the-dia-2024-global-annual-meeting/) - Stop by ACRO’s Bayfront Reception at DIA’s 2024 Global Annual Meeting. About the Reception Heading to San Diego for DIA 2024? Join ACRO for a lively bayfront reception with industry colleagues new and old! Stop by for drinks and hors d’oeuvres with a view of the Bay. Date & time:Tuesday, June 18, 20246:00 – 7:30
- [ACRO & Research! America Survey, 2023](https://www.acrohealth.org/acro-research-america-survey-2023/) - ACRO & Research! America Survey, 2023 Commissioned by ACRO and Research!America, the October 2023 national survey captures Americans’ views on clinical trials and clinical research. Finding 1 Finding 2 Finding 3 Finding 4 Finding 5 Finding 6 The survey found that an overwhelming majority of Americans (87%) agree that health care professionals should discuss clinical
- [RBQM 2023 Summary Report](https://www.acrohealth.org/rbqm-summary-2023/) - Summary Report A survey of ACRO member companies shows how risk-based approaches are used in clinical trials Overview Highlights Key Takeaways In early 2022, ACRO conducted the third consecutive year of its annual landscape survey, and this report highlights key findings. The aim of the survey is to answer ACRO member companies’ and global regulators’
- [Celebrating ACRO’s 20th Anniversary](https://www.acrohealth.org/celebrating-acros-20th-anniversary/) - A Survey of ACRO Member Companies Shows How Risk-Based Approaches Are Used in Clinical Trials 20 Years of Excellence Formed in 2001, the Association of Clinical Research Organizations (ACRO) represents clinical research and technology companies that support a majority of clinical trials around the world, contributing to the development of new drugs and treatments for
- [Contact](https://www.acrohealth.org/contact/) - Contact the Association of Clinical Research Organizations info@acrohealth.org 601 New Jersey Ave NW, Suite 350, Washington DC, 20001
- [Privacy Policy](https://www.acrohealth.org/privacy-policy-2/) - Last updated: October 14, 2021 This Privacy Policy describes our policies and procedures on the collection, use and disclosure of your information when you use our website and tells you about your privacy rights and how the law protects you. We use your personal data to provide and improve our website. By using our website,
- [Current Members](https://www.acrohealth.org/current-members/) - Our members are global clinical research and technology companies.
- [Leadership](https://www.acrohealth.org/acro-leadership/) - This is just placeholder text. Don’t be alarmed, this is just here to fill up space since your finalized copy isn’t ready yet. Once we have your content finalized, we’ll replace this placeholder text with your real content.
- [Leadership](https://www.acrohealth.org/leadership/) - ACRO is led by a distinguished team of industry, drug development, and technology experts that comprise ACRO’s Board of Directors. Our Board of Directors is dedicated to advocating on behalf of safe, efficient, and effective clinical trials that protect patients and ensure high-quality results. All Regular ACRO members maintain a seat on our Board of
- [How do Ideas Become Medicines?](https://www.acrohealth.org/patient-resources/ideas-to-medicines/) - Developing innovative new medicines is a long and complex process.Learn how global collaboration helps bring new drugs to patients. The drug development process — involving discovery, pre-clinical research, clinical trials and regulatory approval — requires a global, collaborative effort. This work involves pharmaceutical company (sponsor) staff, clinical research and technology organizations (ACRO members), government regulators,
- [About ACRO](https://www.acrohealth.org/about-acro/) - This is just placeholder text. Don’t be alarmed, this is just here to fill up space since your finalized copy isn’t ready yet. Once we have your content finalized, we’ll replace this placeholder text with your real content. This is just placeholder text. Don’t be alarmed, this is just here to fill up space since
- [Standard Internal](https://www.acrohealth.org/standard-internal/) - This is just placeholder text. Don’t be alarmed, this is just here to fill up space since your finalized copy isn’t ready yet. Once we have your content finalized, we’ll replace this placeholder text with your real content. Sometimes it’s nice to put in text just to get an idea of how text will fill
- [Decentralized Clinical Trials Data Flow Maps](https://www.acrohealth.org/dctdataflow/) - Data integrity and data quality are key pillars of clinical research. The ACRO DCT Data Flow Maps are designed to build confidence and trust in decentralized clinical trials by providing transparency and visibility into data flow, data controls, and data traceability within a DCT to illustrate how a decentralized model guards data quality and integrity.
- [Risk-based Monitoring in Clinical Trials: Past, Present & Future](https://www.acrohealth.org/rbqmlandscape/) - ACRO’s RBQM report shows how clinical trials were forced to shift to remote monitoring during the COVID-19 pandemic, and highlights why the industry shouldn’t turn back. Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand the RBM implementation
- [ACRO’s Decentralized Trials Toolkit](https://www.acrohealth.org/acros-decentralized-trials-toolkit/) - ACRO’s DCT Toolkit Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide Decentralized Clinical Trials Risk Assessment Considerations Decentralized Clinical Trials Data Flow Maps Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials The Quality-by-Design Manual for
- [ACRO in ACTION: Insights from the COVID-era](https://www.acrohealth.org/acro-in-action/) - The COVID-19 pandemic has sparked extraordinary activity in the clinical research and technology industry. Urgency has driven evolution: The industry has adapted, taken risks and innovated – with changes large and small – in response to a global crisis. Check out our series of blog posts, interviews, and videos from our members companies on how they have adapted
- [Risk-Based Monitoring in Clinical Trials: 2021 Update](https://www.acrohealth.org/rbqm-2021-update/) - A Survey of ACRO Member Companies Shows How Risk-Based Approaches Are Used in Clinical Trials In early 2022, ACRO conducted the third consecutive year of its annual landscape survey, and this report highlights key findings. The aim of the survey is to answer ACRO member companies’ and global regulators’ interest in understanding how risk-based monitoring
- [Decentralized Clinical Trials](https://www.acrohealth.org/dct/) - In October 2019, ACRO established the Decentralized Clinical Trials Working Party to examine the barriers to adoption of DCTs and create quality-based principles and tools to facilitate implementation of decentralized clinical trials. Thought Leadership on DCTs ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual;
- [Risk-based Monitoring in Clinical Trials: Increased Adoption Throughout 2020](https://www.acrohealth.org/rbqmincreasedadoption/) - ACRO’s new RBQM report provides a comprehensive update on the RBM implementation landscape, using the results of ACRO’s latest 2020 landscape survey results. With the emergence of new technologies for data collection, the continued impact of the COVID-19 pandemic, and the increasing number of partially or fully decentralized clinical trials (DCTs), the importance of risk-based
- [QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide](https://www.acrohealth.org/qbdguide/) - The QbD Manual Quick Reference Guide was created to provide a more readily accessible and easily digestible version of the full-length ACRO DCT QbD Manual.
- [ACRO Statements on Innovation](https://www.acrohealth.org/acro-statement-innovation/) - The expertise and innovation of ACRO member companies helps speed the clinical trialprocess and the development of safe and effective therapies. See below for ACRO’s statements on innovation. Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight ACRO’s CRO Forum’s paper enables greater collaboration and efficiency through a shared vision
- [ACRO News](https://www.acrohealth.org/acros-latest-news/) - Decentralized Trials In October 2019, ACRO established the Decentralized Clinical Trials Working Party to examine the barriers to adoption of DCTs and create quality-based principles and tools to facilitate implementation of decentralized clinical trials. Read more here.
- [ACRO’s Considerations on Monitoring During COVID-19](https://www.acrohealth.org/acro-considerations-on-monitoring-during-covid-19/) - On 13 March 2020, ACRO released a list of considerations that support clinical trial monitoring oversight during COVID-19. ACRO recommends that sponsors, clinical research sites, CROs, and technology companies use these emergency interim measures so that clinical trial monitoring is maintained during the current public health crisis. These recommendations will ensure that data quality is
- [COVID-19 Member Corner](https://www.acrohealth.org/covid-19-members/) - ACRO and its members are committed to helping speed the clinical trial process and the development of safe and effective therapies for COVID-19. Take a look at some of the stories below to see how our member companies are responding to this crisis.
- [COVID-19 Resource Center](https://www.acrohealth.org/covid-19-resources/) - ACRO is closely tracking the clinical research industry’s response to COVID-19. You can find guidance from regulators below. We will continue to update this to keep our members informed.
- [Explore How ACRO Delivers Value](https://www.acrohealth.org/why-join-acro/) - ACRO is uniquely positioned to champion the interests of the clinical research industry. Scroll to explore the ways we are delivering value to our members, partners, and to patients.
- [Clinical Trial Resources for Patients](https://www.acrohealth.org/patient-resources-v2/) - Choosing to participate in a clinical trial is an important personal decision. These resources can help you learn more about clinical research, what participating in a trial may mean for you and how to find a trial of interest. How do ideas become medicines? Developing innovative new medicines is a long and complex process. Learn
- [Clinical Trial Participation](https://www.acrohealth.org/clinical-trial-participation/) - Clinical trials present patients and participants with the opportunity to not only contribute to medical research that helps spur the development of new drugs, devices, or procedures — but also to play a more active role in their healthcare and access innovative new treatments before they are widely available. Who can participate? All clinical trials
- [Clinical Trial Resources for Patients](https://www.acrohealth.org/patient-resources/) - Choosing to participate in a clinical trial is an important personal decision. These resources can help you learn more about clinical research, what participating in a trial may mean for you and how to find a trial of interest. How do ideas become medicines? Developing innovative new medicines is a long and complex process. Learn
- [ACRO’s alliances: Advancing the clinical research enterprise around the world](https://www.acrohealth.org/acro-alliances/) - By working together with related groups, ACRO encourages cross-industry cooperation, promotes ACRO’s policy positions and create new opportunities for our members. ACRO’s alliances include: Advocacy and Education Coalitions The Alliance for a Stronger FDA works for increased appropriations to strengthen the FDA. The Alliance for Regenerative Medicine (ARM) educates key policymakers about the potential of regenerative medicine
- [Frequently Asked Questions: Understanding Clinical Trials](https://www.acrohealth.org/patient-resources-v2/faq-about-clinical-trials/) - Choosing to participate in a clinical trial is an important personal decision. Use this FAQ to be more informed. This FAQ offers information about clinical trials, how they operate and what it means to be a trial participant. If you have additional questions, talk to your healthcare provider. How can I participate in a clinical
- [The Value of Clinical Research and Technology Organizations](https://www.acrohealth.org/value-of-clinical-research-organizations/) - Clinical Research Organizations (CROs) play a major role in ensuring safe, ethical clinical trials that help spur the development of new, life-saving drugs and medical devices that benefit millions of patients worldwide. GLOBAL IMPACTS OF CLINICAL RESEARCH Clinical research and technology organizations have an enormous, positive impact on the drug development process in addition to
- [Government Agency Resources](https://www.acrohealth.org/resources-other-agencies/) - Use these resources for country-specific information on clinical research, regulations and policies governing research trials International World Health Organization International Conference on Harmonisation Asia Pacific/Middle East/Africa Australia Department of Health and Ageing Therapeutic Goods Administration (TGA) China State Drug Administration of Traditional Chinese Medicines of the People’s Republic of China National Institute for the Control
- [ACRO Member Code of Ethics](https://www.acrohealth.org/acro-member-code-of-ethics/) - The Association of Clinical Research Organizations (ACRO) and its members (Members) are dedicated to ethical and lawful behavior in performing clinical research. To evidence this commitment, ACRO has adopted the following principles: 1. We are dedicated to the protection and maintenance of the rights and safety of human participants in all aspects of clinical research.
- [US Legislation & Regulation](https://www.acrohealth.org/us-legislation-and-regulation/) - Enabling Clinical Research by Advancing US Legislation and Regulation Half of all clinical trials take place in the United States. That’s why ACRO works with US legislators and regulators to ensure a positive regulatory and business environment that supports high-quality, safe and ethical clinical research. ACRO’s US agenda is focused on promoting policies that foster innovation and
- [Members Innovation Hub](https://www.acrohealth.org/members-hub/) - ACRO represents the clinical research and technology companies that are committed to innovating drug development and clinical trials. Take a look at how our members are innovating in these focus areas:
- [The Global Clinical Research Industry’s Commitment to COVID-19 Collaboration](https://www.acrohealth.org/covid-19/) - ACRO and its members are committed to collaborating with regulators and biopharmaceutical organizations worldwide to develop vaccines and anti-viral therapies to prevent, diagnose, and treat COVID-19. The expertise and innovation of ACRO member companies helps speed the clinical trial process and the development of safe and effective therapies. ACRO’s clinical research and technology companies are
- [Clinical Research Roundtables](https://www.acrohealth.org/clinical-research-roundtables/) - ACRO is an industry catalyst. We convene candid discussions with policy makers to offer firsthand perspectives about the clinical research industry, our impact and opportunities for productive collaboration.Our work sparks action. DEVELOPING AND EXTENDING RELATIONSHIPS Policy makers are not as familiar with the clinical research industry as they should be, given our size and impact.
- [Diversity and Inclusion in Clinical Trials](https://www.acrohealth.org/di/) - In December 2020, ACRO established the Diversity & Inclusion in Clinical Trials Committee to address the need for improving diversity and inclusion across the clinical research ecosystem.
- [European Legislation & Regulation](https://www.acrohealth.org/european-legislation-and-regulation/) - Advancing Industry Interests in European Legislation and Regulation With nearly 30 percent of all clinical trials taking place in Europe, ACRO engages with regulators to support – and provide the clinical research industry’s expertise on – harmonization efforts such as the EU Clinical Trial Regulation and the EU General Data Protection Regulation (GDPR). ACRO’s European-focused Activities Participate in invitation-only,
- [Addressing Industry Pain Points](https://www.acrohealth.org/addressing-industry-pain-points/) - A proactive agenda focused on policy outcomes to advance specific operational interests of ACRO members. LEARN MORE ACRO directly engages regulators, customers and other stakeholders to facilitate our collective input on issues and initiatives such as the 21st Century Cures Act and the EU Clinical Trial Regulation. In 2017, ACRO’s Board of Directors established a committee to develop a
- [Global Data Protection & Privacy](https://www.acrohealth.org/global-data-protection-privacy/) - Preparing for an increasingly data-linked future. The clinical research industry is preparing for an increasingly data-linked future. ACRO’s GDPP Committee connects representatives of Member companies with a range of stakeholders on important issues of privacy, data protection and data security. The Committee’s efforts focus on how the industry interprets policies and prepares for upcoming legislation.
- [CFO Roundtable](https://www.acrohealth.org/cfo-roundtable/) - Accounting standards, industry-wide principles and more Challenge: New Standards With the significant technical and IR communications considerations relating to the transition to the new revenue standard ASC 606, the Board of Directors of ACRO approved formation of a CFO Roundtable to allow discussion of challenges faced by our industry and consideration of the potential for
- [Toward 2025: Transforming Clinical Research Through Digital Innovation](https://www.acrohealth.org/toward-2025-transforming-clinical-research-through-digital-innovation/)
- [Communications](https://www.acrohealth.org/communications/)
- [Privacy Policy](https://www.acrohealth.org/privacy-policy/) - Last updated: October 14, 2021 This Privacy Policy describes our policies and procedures on the collection, use and disclosure of your information when you use our website and tells you about your privacy rights and how the law protects you. We use your personal data to provide and improve our website. By using our website,

## Informed Content Hub

- [From Trusted Care to Trusted Research: Health Centers as Clinical Trial Partners ](https://www.acrohealth.org/informed-content-hub/from-trusted-care-to-trusted-research-health-centers-as-clinical-trial-partners/) - Written by: Rose Blackburne, MD, MBA, Vice President and Head of Population Science Strategy and Women’s Health Paula Underhill, Senior Director and Head of Strategic Site Collaborations Meghan Cox, MPH, Associate Director, Population Science Strategy National Health Center Week provides an opportunity to recognize the far-reaching impact of community health centers in improving health outcomes. For millions
- [How Small Grants Drive Big Changes Through Site-Led Innovation](https://www.acrohealth.org/informed-content-hub/how-small-grants-drive-big-changes-through-site-led-innovation/) - Good Clinical Podcast: Season 4, Episode 2 How Small Grants Drive Big Changes Through Site-Led Innovation This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Good Clinical Podcast Season 4 Episode 2 is now available, featuring a lively discussion on ACRO's Site Resource Grants program and its potential to shape the future
- [Moving from Awareness to Execution in Trial Representation](https://www.acrohealth.org/informed-content-hub/moving-from-awareness-to-execution-in-trial-representation/) - Good Clinical Podcast: Season 4, Episode 8 Moving from Awareness to Execution in Trial Representation This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Tinaya Gray (Executive Director, Site Engagement & PACE at ICON plc), Jan Hewett (SVP, FDA Regulatory Advisor at Advarra), and Jackie Kent (Independent Advisor) unpack the work of
- [Advancing Sustainability Through Smarter Clinical Trial Design](https://www.acrohealth.org/informed-content-hub/advancing-sustainability-through-smarter-clinical-trial-design/) - Good Clinical Podcast: Season 4, Episode 7 Advancing Sustainability Through Smarter Clinical Trial Design This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Artificial intelligence is shaping clinical research, and its impact extends far beyond automation. In this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined byPaulo Limgenco (VP,
- [Collaborating to Drive Global Progress in Clinical Research](https://www.acrohealth.org/informed-content-hub/collaborating-to-drive-global-progress-in-clinical-research/) - Good Clinical Podcast: Season 4, Episode 6 Collaborating to Drive Global Progress in Clinical Research This episode is available to stream on Spotify, Apple Podcasts, and YouTube. What does it take to run successful clinical trials across borders? Tune in asChris Boone (Group VP, Research, Health & Life Sciences at Oracle) and Alicia Baker McDowell
- [Advancing Rare Disease Research Through AI Innovation and Patient Trust](https://www.acrohealth.org/informed-content-hub/advancing-rare-disease-research-through-ai-innovation-and-patient-trust/) - Good Clinical Podcast: Season 4, Episode 5 Advancing Rare Disease Research Through AI Innovation and Patient Trust This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Artificial intelligence is rapidly reshaping the landscape of rare disease research -- but how close are we to realizing its full potential? In this episode, Tanya
- [Improving Site Feasibility Through Better Data Collaboration and Timing](https://www.acrohealth.org/informed-content-hub/improving-site-feasibility-through-better-data-collaboration-and-timing/) - Good Clinical Podcast: Season 4, Episode 4 Improving Site Feasibility Through Better Data Collaboration and Timing This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Site feasibility remains a critical yet complex component of clinical trial startup. In this episode, listen as Andrea Bastek (VP, Market Strategy at Florence Healthcare), Christine Senn
- [Evolving Patient Engagement from Transactional to Transformational](https://www.acrohealth.org/informed-content-hub/evolving-patient-engagement-from-transactional-to-transformational/) - Good Clinical Podcast: Season 4, Episode 3 Evolving Patient Engagement from Transactional to Transformational This episode is available to stream on Spotify, Apple Podcasts, and YouTube. What does "patient-centricity" actually look like in practice, and why does it still fall short? In this episode, Stacy Hurt (Chief Patient Officer at Parexel) and Alicia Staley (Chief
- [Centralized Monitoring at Work: Playing Telephone Compromises Protocol Compliance](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-playing-telephone-compromises-protocol-compliance/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [Centralized Monitoring at Work: Dialing in on Protocol Deviations](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-dialing-in-on-protocol-deviations/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [Celebrating Breakthroughs, Breaking Barriers, and Dismantling Misconceptions at DIA 2026](https://www.acrohealth.org/informed-content-hub/celebrating-breakthroughs-breaking-barriers-and-dismantling-misconceptions-at-dia-2026/) - DIA 2026, held June 14-18, 2026, brought thousands of professionals from the clinical research industry, regulatory agencies, and patient advocacy to tackle the issues and challenges shaping healthcare and furthering innovation today. The 4-day conference featured an exchange of diverse perspectives, cutting-edge scientific insights, and regulatory expertise across the therapeutic lifecycle, exploring topics like artificial
- [Executing at Scale: Why Alzheimer’s Disease Drug Development Demands a Different Kind of Partner](https://www.acrohealth.org/informed-content-hub/executing-at-scale-why-alzheimers-disease-drug-development-demands-a-different-kind-of-partner/) - Written by: Andreas Lysandropoulos, MD, PhD, Franchise Head, Neurosciences, Ophthalmology, and Rare Diseases, Parexel Alzheimer’s disease drug development has reached an inflection point, and the challenge it presents is not only scientific but structural. Today, many therapies that have cleared regulatory hurdles are failing to reach patients at scale because health care providers and payers
- [Designing Psychiatric Trials for Meaningful Evidence](https://www.acrohealth.org/informed-content-hub/designing-psychiatric-trials-for-meaningful-evidence/) - Written by:Krista Armstrong, Senior Vice President and Global Head, Neuroscience, Premier Research Mental Health Awareness Month offers an important moment to reflect on the continued need for more effective, well-tolerated and safe psychiatric treatments. Across clinical research, demand remains high for mood disorders, anxiety disorders, psychotic conditions, and other serious mental health challenges that continue
- [Building a Global AI Framework for Clinical Trials](https://www.acrohealth.org/informed-content-hub/building-a-global-ai-framework-for-clinical-trials/) - Good Clinical Podcast: Season 4, Episode 1 Building a Global AI Framework for Clinical Trials This episode is available to stream on Spotify, Apple Podcasts, and YouTube. ACRO's Good Clinical Podcast returns for Season 4, exploring the current state of clinical research and the path forward for improving trials for patients. Host Sophia McLeod is
- [During National Minority Health Month, Recognition Matters, but Progress Requires Continued Action](https://www.acrohealth.org/informed-content-hub/during-national-minority-health-month-recognition-matters-but-progress-requires-continued-action/) - Written by:Ashley Moultrie, Associate Director of Clinical Trial Diversity, Syneos Health Every year, National Minority Health Month gives us an important opportunity to pause and reflect. It gives us the space to recognize the health disparities that continue to shape healthcare experiences and outcomes for far too many. It also acknowledges the individuals and communities
- [Scaling Innovative Clinical Trial Approaches: Exploring Challenges, Progress, and Opportunities at an FDA & Duke Margolis Public Workshop](https://www.acrohealth.org/informed-content-hub/scaling-innovative-clinical-trial-approaches-exploring-challenges-progress-and-opportunities-at-an-fda-duke-margolis-public-workshop/) - ACRO staff and several ACRO member companies attended the FDA & Duke Margolis Public Workshop: Scaling Innovative Clinical Trial Approaches: Challenges, Progress, and Opportunities. The workshop, held earlier this week, brought together regulators, industry leaders, and clinical research stakeholders to discuss the evolving landscape of clinical trial innovation, with a strong focus on collaboration, patient-centricity, and operational scalability.
- [Holistic Patient Safety: Reframing Technology’s Role in Safer Clinical Trials](https://www.acrohealth.org/informed-content-hub/holistic-patient-safety-reframing-technologys-role-in-safer-clinical-trials/) - Written by:Andrea Bastek, VP Market Strategy, Florence Healthcare Patient Safety Awareness Week (March 9–15, 2026) is a powerful reminder that patient protection is the foundation of clinical research, and it’s worth asking: Are we thinking about patient safety holistically? Too often, safety is reactively assessed through downstream mechanisms such as adverse event reporting, monitoring activities
- [Exploring the Future of Clinical Research in India](https://www.acrohealth.org/informed-content-hub/exploring-the-future-of-clinical-research-in-india/) - Written by:Clay Alspach, JD, Executive Director, ACRO ACRO was proud to join leaders from across the global clinical research community at the Indian Society for Clinical Research (ISCR) 19th Annual Conference, engaging with regulators and industry partners to discuss the future of clinical research in India. Throughout the conference, ACRO representatives contributed to panels and discussions focused on
- [Equitable Care, Accelerated Timelines: Expanding Global Access to Rare Disease Research](https://www.acrohealth.org/informed-content-hub/equitable-care-accelerated-timelines-expanding-global-access-to-rare-disease-research/) - Written by:Rachel Smith, Vice President, Rare and Genetic Diseases, Parexel For Rare Disease Day 2026, the international rare disease community is calling for equitable treatment and care access — and that includes access to clinical trials. Since more than 95% of rare diseases have no approved treatment, clinical trials are a crucial care option for
- [Case Studies Highlight the Value of a Centralized Monitoring Approach to Data Monitoring](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-centralized-monitoring-case-studies/) - Good Clinical Podcast: Season 3, Episode 2 Experts Share 3 Main Benefits of Implementing Centralized Monitoring On this week’s episode, host Sophia McLeod is joined by Danilo Branco (Associate Director, Risk Based Quality Management Lead, BeOne Medicines) and Amanda Coogan (Associate Director, Customer Experience, Remarque Systems) to discuss the value of centralized monitoring implementation by sharing case studies from
- [More than a Statistic: What EU Joint Clinical Assessment Changes for Oncology Patients](https://www.acrohealth.org/informed-content-hub/more-than-a-statistic-what-eu-joint-clinical-assessment-changes-for-oncology-patients/) - Written by:Dr. Liz O'Brien, Therapeutic Expert, Oncology & Women's Health, Drug Development Solutions, ICON World Cancer Day’s campaign theme is “united by unique”. It invites the world to see people living with cancer as “more than a disease, more than a statistic”. For oncology sponsors it is a day to reflect on progress made on
- [ACRO's 2025 Clinical Research Regulatory and Legislative Wrap-up](https://www.acrohealth.org/informed-content-hub/acros-2025-clinical-research-regulatory-and-legislative-wrap-up/) - Written by:Karen Noonan, Senior Vice President, Global Regulatory Policy at ACROSophia McLeod, Advocacy Advisor at ACROFiona Lewis, Advocacy Associate at ACRO 2025 brought unprecedented turbulence to the clinical research ecosystem in the U.S., with changes to HHS, FDA, and Congress, as well as in the EU and UK, fundamentally shifting how these bodies interact with
- [Why Drug Safety in Pregnancy Remains a Critical Topic](https://www.acrohealth.org/informed-content-hub/why-drug-safety-in-pregnancy-remains-a-critical-topic/) - Written by:Anne Broe Lambourne, MD PhD, Engagement Manager at Epidemiology & Scientific Strategy, Real World Evidence, IQVIAEmily W. Bratton, MSPH, PhD, Senior Director of Applied AI Science at IQVIA The effects of prescription drug exposure during pregnancy remain a significant unknown and evidence gap for many important treatments. For individuals managing chronic illnesses, such as
- [Is the Future of Clinical Trials in Hospitals or Homes?](https://www.acrohealth.org/informed-content-hub/is-the-future-of-clinical-trials-in-hospitals-or-homes/) - Written by:Kieran Connolly, MD, Senior Director of eCOA Strategy at Veeva Note: This article first appeared in the New Scientist. We have republished it in its entirety here with their permission. For decades, clinical trials have primarily taken place in hospitals and specialised centres, known as “sites”. Patients visit these sites for regular appointments, medication administration, and
- [ The Women Changing the Clinical Research Landscape ](https://www.acrohealth.org/informed-content-hub/the-women-changing-the-clinical-research-landscape-2/) - Good Clinical Podcast: Season 1, Episode 6 Women's Impact on Science This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Cyndi Verst (President, R&DS Design & Delivery Innovation, IQVIA) and Peyton Howell (Chief Operating & Growth Officer, Parexel).
- [Expert Discussion: Centralized Monitoring's Role in Effective RBQM for Clinical Trials ](https://www.acrohealth.org/informed-content-hub/expert-discussion-centralized-monitorings-role-in-effective-rbqm-for-clinical-trials/) - Good Clinical Podcast: Season 2, Episode 7 Risk-Based Quality Management for Centralized Monitoring This episode is available to stream on Spotify, Apple Podcasts, and YouTube. This week, ACRO’s Good Clinical Podcast returns for a special episode! Lauren Garson (Senior Director, Clinical Strategy, Veeva), Nicole Stansbury (Senior Vice President, Global Clinical Operations, Premier Research), and Jennifer Stewart (Executive Director, Clinical Data Sciences, Premier
- [The State of Clinical Research in the UK in 2024](https://www.acrohealth.org/informed-content-hub/the-state-of-clinical-research-in-the-uk-in-2024/) - Good Clinical Podcast: Season 2, Episode 6 UK Clinical Trial Updates and Key Developments This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On the season 2 finale of ACRO’s Good Clinical Podcast, Steve Cutler (CEO, ICON plc) and Professor Lucy Chappell (CEO, NIHR) join the podcast to discuss the current clinical research landscape in the
- [2019 -2024 Data on Risk-Based Quality Management in Clinical Research](https://www.acrohealth.org/informed-content-hub/2019-2024-data-on-risk-based-quality-management-in-clinical-research/) - Good Clinical Podcast: Season 2, Episode 5 Enhancing Data Quality with Risk-Based Monitoring (RBQM) This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On the latest episode of ACRO’s Good Clinical Podcast, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical
- [Ethical and Compassionate Pediatric Research in Action  ](https://www.acrohealth.org/informed-content-hub/the-women-changing-the-clinical-research-landscape/) - Good Clinical Podcast: Season 2, Episode 4 Pediatric Clinical Trials and Tangible Compassion This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On the latest episode of ACRO’s Good Clinical Podcast, Susan McCune, MD (VP, Pediatrics & Clinical Pharmacology, The PPD clinical research business of Thermo Fisher Scientific) and Jacqui Whiteway, PhD (Senior Director & Pediatric
- [Understanding the Latest ICH E6 (R3) Guidelines](https://www.acrohealth.org/informed-content-hub/understanding-the-latest-ich-e6-r3-guidelines/) - Good Clinical Podcast: Season 2, Episode 3 The Latest Good Clinical Practice Guidelines This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to
- [Pioneering Voices: Women Impacting Clinical Research ](https://www.acrohealth.org/informed-content-hub/pioneering-voices-women-impacting-clinical-research/) - Good Clinical Podcast: Season 1, Episode 1 Women in Clinical Research (Part 1) This episode is available to stream on Spotify, Apple Podcasts, and YouTube. Today, ACRO is thrilled to announce the Good Clinical Podcast, where we take a look at the current state of clinical research and what direction the industry must head in
- [ Leveraging AI to Achieve Empathetic Patient Centricity](https://www.acrohealth.org/informed-content-hub/leveraging-ai-to-achieve-empathetic-patient-centricity/) - Good Clinical Podcast: Season 2, Episode 1 Prioritizing the Patient Experience in Trials This episode is available to stream on Spotify, Apple Podcasts, and YouTube. To kick off the season, ACRO’s Sophia McLeod is joined by Stacy Hurt (Chief Patient Officer, Parexel) and Alicia Staley (Vice President, Patient Engagement, Medidata). Stacy and Alicia discuss how
- [Clinical Trials and International Discourse ](https://www.acrohealth.org/informed-content-hub/clinical-trials-and-international-discourse/) - Good Clinical Podcast: Season 1, Episode 2 The Global Landscape of Clinical Trials This episode is available to stream on Spotify, Apple Podcasts, and YouTube. In episode 2 of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Lord James O’Shaughnessy (Newmarket Strategy), Alistair MacDonald (GHO Capital Partners), and Leona Fitzgerald (PPD, Part of
- [Challenges and Opportunities with AI and ML in Clinical Trials ](https://www.acrohealth.org/informed-content-hub/challenges-and-opportunities-with-ai-and-ml-in-clinical-trials/) - Good Clinical Podcast: Season 1, Episode 3 Navigating the Complexities of Clinical Research This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On episode 3 of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Lisa Moneymaker (Saama Technologies) and Stephen Pyke (Parexel) to discuss current and future uses of AI
- [Sustainable Change in Clinical Trials](https://www.acrohealth.org/informed-content-hub/sustainable-change-in-clinical-trials/) - Good Clinical Podcast: Season 1, Episode 4 Diversity and Inclusion in Healthcare Innovation This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod sat down with Kimberly Richardson (Patient Advocate & Founder, Black Cancer Collaborative) to talk about what is still missing
- [The Future of Rare Disease Research](https://www.acrohealth.org/informed-content-hub/the-future-of-rare-disease-research/) - Good Clinical Podcast: Season 2, Episode 2 AI in Research and Regulation This episode is available to stream on Spotify, Apple Podcasts, and YouTube. On the latest episode of ACRO’s Good Clinical Podcast, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer,
- [Reflecting on the Wins and Challenges of 2025](https://www.acrohealth.org/informed-content-hub/reflecting-on-the-wins-and-challenges-of-2025/) - Written by: Erin Brown, Director of Industry Intelligence and Messaging at ACRO Amid the geopolitical, economic, and regulatory uncertainties of 2025, ACRO worked alongside our members to drive high-quality and innovative clinical research. This year, we have navigated unprecedented turmoil at HHS and the FDA, including a 20 percent reduction in workforce, striking changes to
- [Site Resource Grant Spotlight: Brooklyn Clinical Research](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-brooklyn-clinical-research/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique local community. In the heart of Brooklyn, New York, Brooklyn Clinical
- [Site Resource Grant Spotlight: Nebraska Cancer Specialists](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-nebraska-cancer-specialists/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique local community. Nebraska Cancer Specialists is working to make clinical research
- [How the Clinical Research Industry Should Integrate AI into Drug Development](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-future-proofing-drug-development/) - Good Clinical Podcast: Season 3, Episode 3 Data Analysis Experts Discuss How the Clinical Research Industry Can Prepare for AI On this week’s episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better
- [Setting the Record Straight on SDR/SDV Sampling Strategies](https://www.acrohealth.org/informed-content-hub/setting-the-record-straight-on-sdr-sdv-sampling-strategies/) - Centralized Monitoring as Best Practice Risk-Based Quality Management (RBQM) in clinical trials centers on detecting, addressing, preventing, and mitigating risks that could undermine patient safety, trial processes, and data quality, enabling clinical operations teams to mitigate risks or address errors quickly and effectively before they compromise trial outcomes. RBQM strategy involves the inclusion of several
- [Site Resource Grant Spotlight: Preferred Clinical Research](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-preferred-clinical-research/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique, local community. Within the Clairton, Pennsylvania community, Preferred Clinical Research’s team is reshaping how underrepresented populations engage with and experience clinical research. With support from an ACRO Site Resource
- [World Patient Safety Day: Protecting Patients from the Start](https://www.acrohealth.org/informed-content-hub/world-patient-safety-day-protecting-patients-from-the-start/) - Sanjay Vyas, President, Safety & Logistics and Country Head of IndiaStacy Hurt, Chief Patient Officer, Parexel For World Patient Safety Day 2025, the World Health Organization (WHO) is spotlighting safe care for every newborn and child with this tagline: “Patient safety from the start.” This is an important reminder to protect all patients, including the
- [Centralized Monitoring at Work: Unveiling Potential Misconduct](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-unveiling-potential-misconduct/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [How AI Can Modernize Clinical Trials and Improve Protocol Design](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-season-3-episode-8/) - Good Clinical Podcast: Season 3, Episode 8 Three Ways AI Can Improve Protocol Design, Drive Efficiency, and Modernize Clinical Operations In this week’s episode, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) join the podcast to discuss how artificial intelligence is transforming today’s
- [Thought Leadership at Research Revolution](https://www.acrohealth.org/informed-content-hub/thought-leadership-at-research-revolution/) - In late October, thought leaders from across the clinical research industry gathered to explore how technology can facilitate connectivity between clinical research sites and sponsors. Research Revolution, powered by Florence Healthcare, an ACRO member company, brought together sites, sponsors, CROs, and clinical technology companies to share insights, strategies, and success stories that are reshaping the
- [The Power of the Patient Voice: Building the Next Generation of Cancer Research Through Empathy, Science, and Collaboration](https://www.acrohealth.org/informed-content-hub/the-power-of-the-patient-voice-building-the-next-generation-of-cancer-research-through-empathy-science-and-collaboration/) - Written by: Alicia Staley, Chief Patient Officer at Medidata Each October, as National Cancer Awareness Month reminds us of both the extraordinary progress and the unfinished work in oncology, I find myself reflecting on the same simple truth that has guided my career in life sciences: the future of cancer research depends on how well
- [Reimagining Health Literacy in the Digital Era](https://www.acrohealth.org/informed-content-hub/reimagining-health-literacy-in-the-digital-era/) - Written by: Pamela Tenaerts, MD, MBA, Chief Medical Officer at Medable Fully 36% of Americans have limited health literacy skills, and among indigent and minority patients in urban areas, this number rises to over 80%.1 That is not just surprising, but unsettling. Health literacy is a foundational concept in modern clinical research. Each October during
- [Why Efficiency Matters More Than Ever in Oncology Drug Development](https://www.acrohealth.org/informed-content-hub/why-efficiency-matters-more-than-ever-in-oncology-drug-development/) - Written by: Dr. Daniel Mazzolenis, SVP in Medical Management at Syneos Health Cancer research has transformed the outlook for millions of patients over the past several decades. Once considered incurable, many cancers now have treatment options that extend life, improve quality of life or even offer the possibility of a cure. Yet despite this momentum,
- [Centralized Monitoring at Work: Detecting Duplicates](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-detecting-duplicates/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [Bonus Episode: Fast Facts on the ACRO D&I Grants Program](https://mailchi.mp/a7e5c13bd112/bonus-episode-acros-good-clinical-podcast?e=[UNIQID]#new_tab) - ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard and Kristen Surdam to discuss ACRO’s new D&I Site Resource Grants Program.
- [How We Can Achieve Environmental Sustainability in Clinical Research](https://www.acrohealth.org/informed-content-hub/how-we-can-achieve-sustainability-in-clinical-research/) - Written by: Clare Campbell-Cooper, Global Head, Digital Health and Innovation at FortreaMichael Cohen, Senior Director, Environmental Sustainability at Thermo Fisher Scientific Note: Campbell-Cooper and Cohen serve as co-chairs of the ACRO Sustainability Committee. About this Good Clinical Podcast Deep Dive Earlier in 2025, ACRO’s Good Clinical Podcast (GCP) launched its third season with a compelling
- [AI Brings Predictive Insights, Inclusivity, and Localization to Clinical Trials](https://www.acrohealth.org/informed-content-hub/ai-brings-predictive-insights-inclusivity-and-localization-to-clinical-trials/) - About this Good Clinical Podcast Deep Dive Earlier this year, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) joined the podcast to share their thoughts on how artificial intelligence can be used to improve clinical operations to expand access to trials and treatments.
- [Site Resource Grant Spotlight: Randomize Now](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-randomize-now/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique local community. For Randomize Now, a clinical research site based in
- [Clinical Researchers Speak About Industry Adoption of Centralized Monitoring and RBQM](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-what-matters-most-clinical-trial-monitoring/) - Good Clinical Podcast: Season 3, Episode 4 The Importance of Risk-based Quality Management, Centralized Monitoring, and Strategic SDV/SDR Sampling What does clinical trial monitoring have in common with growing a field of corn? Tune into this week’s podcast episode to find out! Amy Kroeplin (Sr. Director Centralized Monitoring, RBQM Global Process Owner, PPD™ clinical research business
- [ACRO Representatives Visit with EU and UK Regulators on Clinical Trials](https://www.acrohealth.org/informed-content-hub/acro-representatives-visit-with-eu-and-uk-regulators-on-clinical-trials/) - Thought leaders across ACRO member companies, including representatives to the ACRO European Regulatory Committee, recently traveled abroad to meet with both EU and UK regulators to advance better, smarter, and faster clinical trials in Europe. On September 2, ACRO joined its first Bilateral Meeting with the European Medicines Agency (EMA) in Amsterdam. ACRO provided recommendations
- [Using AI to Test Protocols on "Virtual Twins" in Clinical Trials](https://www.acrohealth.org/informed-content-hub/using-ai-to-test-protocols-on-virtual-twins-in-clinical-trials/) - Using AI to Test Protocols on “Virtual Twins” in Clinical Trials
- [Centralized Monitoring at Work: Driving eDiary Compliance](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-driving-ediary-compliance/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the second post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [CROs Consider the Environmental Impacts of Clinical Research](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-environmental-sustainability-in-research/) - Good Clinical Podcast: Season 3, Episode 1 Innovation Leaders Talk About Ways to Lessen Our Impact ACRO’s Good Clinical Podcast is back for season 3! To kick off the season, host Sophia McLeod is joined by Clare Campbell-Cooper (Global Head, Digital Health and Innovation, Fortrea) and Michael J. Cohen (Sr. Director, Lead, Environmental Sustainability, PPD™ clinical research business of
- [ACRO Joins FDA Listening Session](https://www.acrohealth.org/informed-content-hub/fda-listening-session/) - In early September 2025, members of ACRO's Risk-Based Quality Management (RBQM) Committee met with representatives from the FDA for our sixth annual listening session with the agency on RBQM adoption in the clinical trial industry. ACRO shared findings and key takeaways from our RBQM landscape survey. Conducted annually over the past six years, this survey
- [Centralized Monitoring at Work: Catching Equipment Issues, Ensuring Data Quality](https://www.acrohealth.org/informed-content-hub/centralized-monitoring-at-work-catching-equipment-issues-ensuring-data-quality/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the fourth post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [Site Resource Grant Spotlight: Superior Clinical Research](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-superior-clinical-research/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their local community. At Superior Clinical Research, based in rural North Carolina, the
- [Implications of ICH E6(R3) on Risk-Based Clinical Trial Practice](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-season-2-episode-3-ich-e6r3-2/) - Good Clinical Podcast: Season 2, Episode 3 How ICH E6(R3) will impact Good Clinical Practice and clinical trial innovation On this episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to discuss ACRO’s collaboration with TransCelerate BioPharma, Inc.,
- [The History of Rare Disease Patient Advocacy and How the Clinical Trial Industry Can Support It](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-future-of-rare-disease-research/) - Good Clinical Podcast: Season 3, Episode 5 Patient Advocacy Leaders Discuss Rare Disease Research Opportunities in Clinical Research Join us for this week’s new episode as Tania Simoncelli and Nasha Fitter come together to discuss how rare disease patient advocacy has transformed over time and how the biopharmaceutical industry should adapt to better meet the needs of
- [Strategic Uses of AI in Clinical Trial Development in 2025](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-ai-clinical-development/) - Good Clinical Podcast: Season 3, Episode 6 Clinical Trial Technology Chiefs Examine How AI Technology is Transforming Clinical Trial Development Malaikannan Sankarasubbu and Jonathan Shough join the Good Clinical Podcast this week to discuss how the strategic use of AI technologies is transforming clinical development.They explore which advancements in generative AI have the potential to improve the clinical trial workflow, the integration
- [Leading Experts Discuss RBQM Trends in Clinical Trials](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-season-3-episode-10/) - Good Clinical Podcast: Season 3, Episode 10 Trends in Risk-Based Monitoring and RBQM in Clinical Trials Join three subject-matter experts to help us wrap Season 3 of ACRO’s Good Clinical Podcast as we discuss trends in RBQM in both ongoing and new start studies. Since 2019, ACRO’s RBQM Working Group has administered a yearly survey
- [ICH E6(R3) Implementation Guidance from Leaders Across the Clinical Trial Industry ](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-season-3-episode-7-the-impact-of-ich-e6r3/) - Good Clinical Podcast: Season 3, Episode 7 Experts Discuss How Sponsors and CROs Can Partner to Improve the State of R3 In ACRO and TransCelerate BioPharma's latest collaboration, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss
- [Lessons from ACRO’s Local Clinical Site Resource Grant Awardees](https://www.acrohealth.org/informed-content-hub/good-clinical-podcast-season-3-episode-9/) - Good Clinical Podcast: Season 3, Episode 9 Local Clinical Trial Site Representatives Explore The State of Clinical Research from a Site Perspective In 2024, ACRO announced its D&I Site Resource Grants Program. Designed to support an innovative 12-month pilot project, the site resource grants act as a platform to incubate innovative strategies for improving representative
- [Site Resource Grant Spotlight: K2 Medical Research](https://www.acrohealth.org/informed-content-hub/grantee-spotlight-k2-medical-research/) - ACRO’s Site Resource Grants are designed to serve as seed funding to help clinical research sites explore innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique local community. K2 Medical Research, awarded a grant from ACRO in
- [Site Resource Grant Spotlight: Smart Cures Clinical Research](https://www.acrohealth.org/informed-content-hub/site-resource-grant-spotlight-smart-cures-clinical-research/) - The ACRO Site Resource Grants are designed to serve as seed funding to help clinical research sites to test innovative strategies for improving clinical trial enrollment. Each grant allows the grantee site to enact a 12-month pilot project designed to educate and engage with their unique local community. Smart Cures Clinical Research, awarded a grant
- [Centralized Monitoring at Work: Rapid Detection Empowered Through CM Protects Patient Safety and Data Integrity](https://www.acrohealth.org/informed-content-hub/case-studies-for-centralized-monitoring-in-practice-in-2025/) - ACRO member companies have compiled a series of case studies that demonstrate how centralized monitoring identifies critical issues more quickly and effectively than traditional on-site monitoring methods. This is the first post in a series highlighting centralized monitoring at work. Check back for more examples of how centralized monitoring has benefited ACRO member companies and
- [Economic Impact of CROs/CTOs on the Biopharmaceutical Industry](https://www.acrohealth.org/informed-content-hub/economic-impact-of-cros-ctos-on-the-biopharmaceutical-industry/) - The U.S. biopharmaceutical industry leads globally in the development of new medicines and remains at the forefront of scientific and technological advances that promise to deliver new treatments and improve health outcomes. Developing and evaluating these drugs requires significant investments—such as securing trial sites, hiring staff and contractors, recruiting, and treating trial volunteers—all of which
- [AI and the Future of Drug Development: What the White House Action Plan Means for Innovative Drug Development](https://www.acrohealth.org/informed-content-hub/ai-and-the-future-of-drug-development-what-the-white-house-action-plan-means-for-innovative-drug-development/) - By ACRO AI/ML Committee Members: Tala Fakhouri, VP, AI & Digital Policy, Real-World Research, Parexel InternationalStephen Pyke, Chief Clinical Data & Digital Officer, Parexel International The White House’s new AI Action Plan is a bold statement of U.S. ambition to lead globally in artificial intelligence (AI) innovation. It lays out a comprehensive strategy to accelerate adoption
- [FDA Changes and Implications: What You Need to Know](https://www.acrohealth.org/informed-content-hub/fda-changes-and-implications-what-you-need-to-know/) - In late March, a wave of changes at HHS and the FDA marked the beginning of what may be a defining moment for the U.S. regulatory landscape. With staffing reductions affecting thousands, remaining FDA employees, industry professionals, and the general public alike are watching closely to understand how these shifts may influence regulatory timelines, policy

## People

- [Judith Ng-Cashin](https://www.acrohealth.org/people/judith-ng-cashin/) - Dr. Ng-Cashin is Novotech’s Chief Medical Officer (CMO), leading the company’s Therapeutic & Scientific Strategy, Quality Assurance, and Drug Development Consulting functions. She joined Novotech in 2023, bringing more than 20 years of international experience across pharmaceutical, biotech, and CRO environments. Based in the United States, Judith provides strategic medical leadership across global programs and
- [Anina Adelfio](https://www.acrohealth.org/people/anina-adelfio/) - Anina Adelfio is the Chief Operating Officer for ACRO. She has been with ACRO since 2015 and in her current role since 2022. Anina works closely with ACRO’s Risk-Based Quality Management (RBQM) team and leads ACRO’s Clinical Trial Continuity Team. She has run a seven-year long project assessing how RBQM principles are applied and utilized
- [Clay Alspach](https://www.acrohealth.org/people/clay-alspach/) - Clay Alspach, JD – Prior to joining ACRO, Clay served as Chief Health Counsel for Chairman Fred Upton of the U.S. House of Representatives Energy and Commerce Committee. During seven years with the committee, he managed, provided strategic direction, and served as the principal representative for the committee on all of its health care-related work. Clay spearheaded legislative initiatives that successfully reformed
- [Karen Noonan](https://www.acrohealth.org/people/karen-noonan/) - Karen joined ACRO in 2014 and leads ACRO’s global regulatory advocacy, engaging with regulators and other policymakers on issues impacting clinical research. She manages ACRO’s US and European regulatory committees and led the ACRO DCT Working Party in the development of the DCT Toolkit. She also leads ACRO engagement with colleague associations such as EFPIA,
- [Maddy Sever](https://www.acrohealth.org/people/maddy-server/) - Maddy joined ACRO staff in 2024 and currently serves as ACRO’s Communications & Membership Associate. Prior to joining ACRO, she has worked campaign roles and for an environmental advocacy coalition. Maddy is a graduate of the University of Mary Washington, where she earned a B.A. in Political Science with a minor in Security & Conflict
- [Erin Brown](https://www.acrohealth.org/people/erin-brown/) - Erin Brown is the Director of Industry Intelligence and Messaging for ACRO. In this role, she manages survey projects assessing ACRO member companies and develops strategic messaging utilizing that data to strengthen advocacy efforts. She earned a BA in Political Science from the University of California, San Diego, and a MPP and a MPH from
- [Fiona Lewis](https://www.acrohealth.org/people/fiona-lewis/) - Fiona joined ACRO in 2025 and serves as ACRO's Advocacy Associate. Before joining ACRO, she worked on Capitol Hill and in D.C. government. Fiona recently earned an MPH in Health Policy & Management from George Washington University and holds a B.S. in health sciences.
- [Gadi Saarony](https://www.acrohealth.org/people/gadi-saarony/) - Gadi Saarony, Chief Executive Officer at Advarra, has over 25 years of leadership experience, including strategic, commercial, and operational clinical research roles. Prior to joining Advarra, Saarony served as Executive Vice President and Chief Clinical Research Services Officer at Parexel and was a member the company’s executive leadership team. Saarony was responsible for the operational
- [Seema Verma](https://www.acrohealth.org/people/seema-verma/) - Executive Vice President and General Manager of Oracle Health and Life Sciences Seema Verma is the Executive Vice President and General Manager of Oracle Health and Life Sciences. In her role, she oversees Oracle’s clinical applications, as well as the company’s portfolio of clinical trial applications. Seema spearheads the delivery of Oracle Health’s next-generation EHR. She is also
- [Sam Srivastava](https://www.acrohealth.org/people/sam-srivastava/) - Sam Srivastava is the chief executive officer of WCG. He is a transformative health care executive with a proven track record of driving growth and innovation in health care delivery. Sam has a passion to deliver better healthcare and is committed to leading with compassion. Prior to WCG, he served as the CEO of NeueHealth
- [Jim Reilly](https://www.acrohealth.org/people/jim-reilly/) - As Vice President of Vault R&D at Veeva, Jim Reilly is responsible for customer engagement, market adoption, and strategic alliances. For the last 15 years, Jim has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content
- [Sandy Kennedy](https://www.acrohealth.org/people/sandy-kennedy/) - Cassandra Strickland Kennedy has served as Chief Quality, Regulatory Affairs, and Sustainability Officer since May 2023 with oversight of Global Regulatory Compliance, Quality Assurance and Environmental, Social and Governance at Fortrea. Sandy brings more than three decades of biopharmaceutical industry experience, with a long track record of success in leadership positions within the pharmaceutical and
- [Lisa Moneymaker](https://www.acrohealth.org/people/lisa-moneymaker/) - Lisa is the Chief Strategy Officer to Drive Transformation at Medidata, overseeing the strategy team, focusing on product advancement, AI-driven trial experiences, and aligning solutions with long-term customer goals. Lisa is a seasoned leader in the intersection of technology and clinical research, with nearly 25 years of experience across pharma, biotech, and medical devices. Her roles
- [Kate Haven](https://www.acrohealth.org/people/kate-haven/) - Kate Haven is Vice President of Investor Relations at ICON plc, a global healthcare intelligence and clinical research organization. Since joining ICON in 2017, Kate has led the investor relations function at ICON for the past four years, after roles in M&A and corporate development that included support of key deals in laboratory services, at-home
- [Margaret Keegan](https://www.acrohealth.org/people/margaret-keegan/) - Margaret Keegan is Chief Executive Officer of Precision Medicine Group, which includes Precision AQ, for next-gen commercialization services and Precision for Medicine, a global CRO and lab services provider. An industry luminary, Margaret has held executive leadership roles at large pharmaceutical and leading life sciences companies. Most recently, Margaret served as Operating Partner at Linden
- [Peyton Howell](https://www.acrohealth.org/people/peyton-howell/) - Peyton Howell is Chief Executive Officer of Parexel and a member of the company’s Board of Directors. She has more than 30 years of pharma services and healthcare industry experience and has represented Parexel on the ACRO Board since 2020, serving as Chairperson for 2024. Peyton served most recently as Chief Operating and Growth Officer
- [Karen Kaucic](https://www.acrohealth.org/people/karen-kaucic/) - Karen Kaucic, M.D., serves as president of patient and advisory services and as chief medical officer for the PPD clinical research business of Thermo Fisher Scientific. As president of patient and advisory services, she oversees two primary business functions: direct-to-patient (DTP) services and advisory services. The former includes responsibility for three early phase clinics, a
- [Cynthia Verst](https://www.acrohealth.org/people/cynthia-verst/) - Dr. Cynthia Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. In this role Dr. Verst is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late phase research for IQVIA, Dr. Verst brings a holistic and
- [Catherine Gregor](https://www.acrohealth.org/people/catherine-gregor/) - Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide. Catherine is a subject matter expert and key opinion leader on patient-centric, decentralized and

## Resources

- [ACRO Comment on Auchincloss Next-Generation U.S. Clinical Development to Accelerate Cures Discussion Draft](https://www.acrohealth.org/resource/acro-comment-on-auchincloss-next-generation-u-s-clinical-development-to-accelerate-cures-discussion-draft/) - As part of its advocacy program in the United States, ACRO submits comments to U.S. legislators. This comment letter, submitted by ACRO to Rep. Jake Auchincloss (D-MA-04) in 2026 on his Next-Generation U.S. Clinical Development to Accelerate Cures discussion draft, can be found below.
- [EDPB Guidelines on Processing Personal Data for Scientific Research](https://www.acrohealth.org/resource/edpb-guidelines-on-processing-personal-data-for-scientific-research/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to the European Data Protection Board (EDPB) on June 25, 2026, regarding the EDPB draft guidelines on processing of personal data for scientific research purposes, can be found below.
- [New Study: Trends in Risk-Based Quality Management](https://www.acrohealth.org/resource/trends-risk-based-monitoring-rbqm-clinical-trials/) - ACRO’s 6-year survey of member company CROs demonstrates how risk-based approaches are increasingly used in clinical trials. In early 2025, ACRO conducted its sixth consecutive landscape survey. The following report highlights ACRO’s key findings for the prior year. The purpose the annual survey is to evaluate adoption levels to improve our understanding of how risk-based
- [AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program](https://www.acrohealth.org/resource/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This RFI response, submitted by ACRO to the FDA in June 2026, on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials, can
- [The Conduct of Clinical Trials during Public Health Emergencies](https://www.acrohealth.org/resource/the-conduct-of-clinical-trials-during-public-health-emergencies/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to the European Medicines Agency (EMA) on April 29, 2026, regarding the EMA's draft guidance on the conduct of clinical trials during public health emergencies can be found below.
- [ICH E22 General Considerations for Patient Preference Studies](https://www.acrohealth.org/resource/ich-e22-general-considerations-for-patient-preference-studies/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2026, in support of the development of a harmonized approach on the use, design, conduct, analysis and submission of patient preference studies (PPS), can be found below.
- [Data Protection Requirements in the Context of Applications for Clinical Research Approval in Ireland](https://www.acrohealth.org/resource/data-protection-requirements-in-the-context-of-applications-for-clinical-research-approval-in-ireland/) - As part of its advocacy program, ACRO submits feedback to foster alignment across industry bodies and regulators. A paper outlining the current approach and regulatory landscape and proposing suitable practical alternatives that the National Office and NRECs might consider can be found below.
- [EMA Draft Reflection Paper on Patient Experience Data (PED)](https://www.acrohealth.org/resource/ema-draft-reflection-paper-on-patient-experience-data-ped/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to the European Commission on January 29, 2026, regarding the EMA Reflection paper on patient experience data can be found below. ACRO offers feedback on this reflection paper emphasizing the importance of incorporation of
- [Appropriate Designations of the Roles of Sponsor and Sites in Data Processing Agreements (DPA) in Clinical Trial Agreements (CTA)](https://www.acrohealth.org/resource/appropriate-designations-of-the-roles-of-sponsor-and-sites-in-data-processing-agreements-dpa-in-clinical-trial-agreements-cta/) - There is inconsistency across the EU in terms of how Data Protection Supervisory Authorities (SA), medicines and healthcare regulators and agencies, ethics committees, and other stakeholders involved in clinical trials view the roles of sponsors and investigators/sites with respect to participant personal data. With the increasing use of new and innovative technologies in clinical studies
- [Postapproval Methods to Capture Safety and Efficacy Data for CGTs](https://www.acrohealth.org/resource/postapproval-methods-to-capture-safety-and-efficacy-data-for-cgts/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2025 on Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products, can be found below.
- [FAQ on DOJ Bulk Transfers Final Rule (Executive Order 14117)](https://www.acrohealth.org/resource/faq-on-doj-bulk-transfers-final-rule-executive-order-14117/) - As part of its advocacy program, ACRO submits feedback to foster alignment across industry bodies and regulators. An FAQ setting out ACRO’s understanding of the DOJ Bulk Transfers Final Rule (90 FR 1636, codified at 28 CFR Part 202). can be found below.
- [Public Questionnaire Informing the European Biotech Act](https://www.acrohealth.org/resource/public-questionnaire-informing-the-european-biotech-act/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to the European Commission on November 7, 2025, regarding the public questionnaire informing the European Biotech Act can be found below. ACRO offers 10 recommendations for inclusion in the EU Biotech Act to help
- [ICH E20: Adaptive Designs for Clinical Trials](https://www.acrohealth.org/resource/ich-e20-adaptive-designs-for-clinical-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2025 on the ICH E20 guidelines on the Adaptive Designs for Clinical Trials, can be found below.
- [Expedited Programs for Regenerative Medicine Therapies for Serious Conditions](https://www.acrohealth.org/resource/expedited-programs-for-regenerative-medicine-therapies-for-serious-conditions/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2025 on the Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, can be found below.
- [Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations](https://www.acrohealth.org/resource/innovative-designs-for-clinical-trials-of-cellular-and-gene-therapy-products-in-small-populations/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2025 on the Innovative Design CGT guidelines on the Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations, can be found below.
- [White House OSTP RFI on Regulatory Reform on Artificial Intelligence](https://www.acrohealth.org/resource/white-house-ostp-rfi-on-regulatory-reform-on-artificial-intelligence/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the White House Office of Science and Technology Policy (OSTP) in 2025 on the draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological
- [ICH E21: Guideline on the Inclusion of Pregnancy and Breastfeeding Individuals in Clinical Trials](https://www.acrohealth.org/resource/ich-e21-guideline-on-the-inclusion-of-pregnancy-and-breastfeeding-individuals-in-clinical-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to U.S. regulators. This comment letter, submitted by ACRO to the FDA in 2025 on the ICH E21 guideline on the Inclusion of Pregnancy and Breastfeeding Individuals in Clinical Trials, can be found below.
- [HHS RFI on Ensuring Lawful Regulation and Unleashing Innovation](https://www.acrohealth.org/resource/hhs-rfi-on-ensuring-lawful-regulation-and-unleashing-innovation/) - As part of its advocacy program in the United States, ACRO submits regulatory comments and Request for Information (RFI) responses to U.S. regulators. This RFI response submitted by ACRO to HHS Secretary Robert F. Kennedy, Jr., on implementing the President’s deregulatory initiatives, can be found below.
- [Exploration of HL7 FHIR for Use in Study Data Created from Real-World Data Sources](https://www.acrohealth.org/resource/exploration-of-hl7-fhir-for-use-in-study-data-created-from-real-world-data-sources/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about the Exploration of HL7 FHIR for Use in Study Data Created from Real-World Data Sources, can be found below.
- [Data Life Cycle Framework](https://www.acrohealth.org/resource/data-lifecycle-framework/) - The Data Life Cycle Framework provides an overview of key considerations throughout the data life cycle to aid understanding of ICH E6(R3) Annex I Section 4. Our goal is that this tool helps enable accurate reporting, verification, and interpretation of clinical trial-related information by providing general considerations to support data integrity, traceability, and security through
- [ACRO Statement for the Record submitted to the Senate Appropriations Committee hearing on Biomedical Research](https://www.acrohealth.org/resource/acro-statement-senate-appropriations-committee-hearing-biomedical-research/) - As part of its advocacy program in the United States, ACRO submits comments to Congress. The following statement for the record was submitted by ACRO to the Senate Appropriations Committee Hearing on “Biomedical Research: Keeping America’s Edge in Innovation" on May 9, 2025. 2026
- [Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products ](https://www.acrohealth.org/resource/considerations-for-the-use-of-artificial-intelligence-to-support-regulatory-decision-making-for-drug-and-biological-products/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products can be found below.
- [Acceptable Ranges for Clinical Trials: Insights from ICH E6(R3)](https://www.acrohealth.org/resource/acceptable-ranges-for-clinical-trials-insights-from-ich-e6r3/) - The Acceptable Ranges Considerations tool, designed to support stakeholders’ internal development and implementation of acceptable ranges under the ICH E6(R3) guideline, details the introduction of acceptable ranges and comparison to E6(R2), key considerations and tips for implementation, and sample use case.
- [Data Matrix Template](https://www.acrohealth.org/resource/data-matrix-template/) - The Data Matrix Template is designed to assist companies as they outline their study data provenance and collection methods, review techniques and frequency (including references to functional plans where reviews are fully described), and conduct data analysis. The framework helps to facilitate the application of ICH E6(R3) requirements for data governance by providing a template
- [Key Risk Management Changes in Good Clinical Practice [ICH E6(R3)]](https://www.acrohealth.org/resource/key-risk-management-changes-in-good-clinical-practice-ich-e6r3/) - An infographic that highlights key changes to the risk management elements within Good Clinical Practice Version 2 and 3. This infographic aims to allow the industry to easily share and digest the impact of risk management elements for efficient ICH E6 (R3) implementation.
- [Control Strategies and Good Clinical Practice [ICH E6(R3)]](https://www.acrohealth.org/resource/control-strategies-and-good-clinical-practice-ich-e6r3/) - ACRO and TransCelerate BioPharma, Inc co-developed this tool that explains control strategies, as laid out in ICH E6(R3). Control strategies can help avoid unnecessary risks, reduce the impact of risks that do occur, and increase the likelihood of detecting a risk quickly, should a risk occur during the course of a clinical trial.
- [Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway](https://www.acrohealth.org/resource/accelerated-approval-and-considerations-for-determining-whether-a-confirmatory-trial-is-underway/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway can be found below.
- [Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics  ](https://www.acrohealth.org/resource/expedited-program-for-serious-conditions-accelerated-approval-of-drugs-and-biologics/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about the Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics can be found below.
- [Provisions Pertaining to Preventing Access to Americans’ Bulk Sensitive Personal Data and U.S. Government-Related Data by Countries of Concern – Notice of Proposed Rulemaking](https://www.acrohealth.org/resource/provisions-pertaining-to-preventing-access-to-americans-bulk-sensitive-personal-data-and-u-s-government-related-data-by-countries-of-concern-notice-of-proposed-rulemaking/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to DOJ in 2024 about Provisions Pertaining to Preventing Access to Americans’ Bulk Sensitive Personal Data and U.S. Government-Related Data by Countries of Concern can be found below.
- [Integrating Randomized Controlled Trials into Routine Clinical Practice](https://www.acrohealth.org/resource/integrating-randomized-controlled-trials-into-routine-clinical-practice/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2024 about Integrating Randomized Controlled Trials into Routine Clinical Practice can be found below.
- [Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices](https://www.acrohealth.org/resource/protocol-deviations-for-clinical-investigations-of-drugs-biological-products-and-devices/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices can be found below.
- [ICH M15: General Principles for Model-Informed Drug Development](https://www.acrohealth.org/resource/ich-m15-general-principles-for-model-informed-drug-development/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 about ICH M15: General Principles for Model-Informed Drug Development can be found below.
- [ICH E6(R3) Good Clinical Practice Guideline: Annex 2](https://www.acrohealth.org/resource/2360/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2025 on Draft Guideline for Good Clinical Practice E6(R3) Annex 2 can be found below.
- [ICH E6(R3) Technology Framework](https://www.acrohealth.org/resource/ich-e6r3-technology-framework/) - The Technology Framework explains the computerized systems (CS) requirements outlined in ICH E6(R3). The framework details potential procedures for using computerized systems, training, security, validation, periodic reviews, system failure, technical support, and user management. Additionally, the framework includes ACRO and TransCelerate’s proposed definitions and outlines potential roles and responsibilities of those involved in the process.
- [Data Governance Framework](https://www.acrohealth.org/resource/datamatrix/) - The Data Governance Framework provides background on data governance, a new section within ICH E6(R3), and its utility in clinical research. The framework connects the entire toolkit of ACRO/TransCelerate data governance solutions to help GCP stakeholders develop a data governance framework.
- [Data Flow Diagram Framework & Template](https://www.acrohealth.org/resource/data-flow-diagram-framework-template/) - The Data Flow Diagram Framework & Template assists companies in developing maps to illustrate relevant data flows between various data collection tools (e.g., EDC, ePRO, eCOA, central labs) and involved stakeholders (e.g., sponsor, CRO, third-party vendors) in a study. The objective of the tool is to increase clarity and coordination among all parties involved.
- [Safeguarding Blinding Considerations Tool](https://www.acrohealth.org/resource/safeguarding-blinding-considerations-tool/) - The Safeguarding Blinding in Data Governance Considerations Tool explains topics necessary to the concept of safeguarding blinding in clinical research. Topics include what blinded data is, why data is blinded, the importance of maintaining blinding, who may be unblinded, and steps to take in case of unblinding.
- [ACRO joins with EFPIA and the IPMPC in comment to European Data Protection Board](https://www.acrohealth.org/resource/acro-joins-with-efpia-and-the-ipmpc-in-comment-to-european-data-protection-board/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Data Protection Board in 2020 about ACRO joins with EFPIA and the IPMPC in comment to European Data Protection Board can be found below.
- [European Platform for Regulatory Science Research](https://www.acrohealth.org/resource/2249/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2024 about the European Platform for Regulatory Science Research can be found below.
- [Risk-Based Quality Management: A Case for Centralized Monitoring](https://www.acrohealth.org/resource/rbqm-centralized-monitoring/) - ACRO’s latest survey on RBQM adoption finds that centralized monitoring is being underutilized despite the potential for increased patient safety oversight and improved data quality. ACRO’s RBQM Working Group is on a mission to help the industry use centralized monitoring more effectively. Risk Based Quality Management (RBQM) in clinical trials centers on detecting, addressing, preventing,
- [Risk-Based Monitoring in Clinical Trials: A 5-Year Summary Report ](https://www.acrohealth.org/resource/risk-based-monitoring-in-clinical-trials-a-5-year-summary-report/) - Drawing on five years of landscape survey data, ACRO’s RBQM Summary Report outlines the current state of RBM & RBQM adoption in the clinical research industry. Findings demonstrate that centralized monitoring is still being underutilized, despite the potential for increased patient safety oversight and improved data quality. Download the ACRO RBQM Summary Report for full
- [ACRO Releases Toolkit to Help Advance DCTs](https://www.acrohealth.org/2021/08/11/acro-releases-toolkit-to-help-advance-decentralized-clinical-trials/)
- [Online Survey Consultation on European Health Data Space (July 2021)](https://www.acrohealth.org/resource/online-survey-consultation-on-european-health-data-space-july-2021/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about Online Survey Consultation on European Health Data Space (July 2021) can be found below.
- [Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs](https://www.acrohealth.org/resource/considerations-for-generating-clinical-evidence-from-oncology-multiregional-clinical-development-programs/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2024 about Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs can be found below.
- [EMA Survey on Simplification of CTIS Sponsor Roles](https://www.acrohealth.org/resource/ema-survey-on-simplification-of-ctis-sponsor-roles/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2024 about EMA Survey on Simplification of CTIS Sponsor Roles can be found below.
- [EMA Guideline on Computerised Systems: Unintended Consequences of the Guideline’s Application to EMRs](https://www.acrohealth.org/resource/ema-guideline-on-computerised-systems-unintended-consequences-of-the-guidelines-application-to-emrs/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2024 about EMA Guideline on Computerised Systems: Unintended Consequences of the Guideline’s Application to EMRs can be found below.
- [Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies](https://www.acrohealth.org/resource/diversity-action-plans-to-improve-enrollment-of-participants-from-underrepresented-populations-in-clinical-studies/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2024 about Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies can be found below.
- [H.R.6000, Cures 2.0 Act Comment Letter](https://www.acrohealth.org/resource/h-r-6000-cures-2-0-act-comment-letter/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in December 2021 about the H.R.6000, Cures 2.0 Act can be found below.
- [Reps. DeGette and Bucshon Request for Information: Next Generation of Cures](https://www.acrohealth.org/resource/reps-degette-and-bucshon-request-for-information-next-generation-of-cures/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in August 2024 about Reps. DeGette and Bucshon's Request for Information: Next Generation of Cures can be found below.
- [Senator Cassidy Request for Information: Exploring Congress’ Framework for the Future of AI](https://www.acrohealth.org/resource/senator-cassidy-request-for-information-exploring-congress-framework-for-the-future-of-ai/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in September 2023 about Senator Cassidy's Request for Information: Exploring Congress’ Framework for the Future of AI can be found below.
- [Office of Science and Technology Policy Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials](https://www.acrohealth.org/resource/office-of-science-and-technology-policy-request-for-information-clinical-research-infrastructure-and-emergency-clinical-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to OSTP in January 2023 about the Office of Science and Technology Policy Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials can be found below.
- [Healthy Futures Task Force Modernization Subcommittee Request for Information: Wearable Technologies, Telemedicine, and Healthcare Modernization](https://www.acrohealth.org/resource/healthy-futures-task-force-modernization-subcommittee-request-for-information-wearable-technologies-telemedicine-and-healthcare-modernization/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to U.S. Congress in March 2022 about the Healthy Futures Task Force Modernization Subcommittee Request for Information: Wearable Technologies, Telemedicine, and Healthcare Modernization can be found below.
- [PREVENT Pandemics Act Discussion Draft](https://www.acrohealth.org/resource/prevent-pandemics-act-discussion-draft/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to U.S. Congress in February 2022 about the PREVENT Pandemics Act Discussion Draft can be found below.
- [Senate Finance Committee International Tax Reform Framework Discussion Draft](https://www.acrohealth.org/resource/senate-finance-committee-international-tax-reform-framework-discussion-draft/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in September 2021 about the Senate Finance Committee International Tax Reform Framework Discussion Draft.
- [Digital Health Technologies for Remote Data Acquisition in Clinical Investigations](https://www.acrohealth.org/resource/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in March 2022 about Digital Health Technologies for Remote Data Acquisition in Clinical Investigations can be found below.
- [Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments](https://www.acrohealth.org/resource/patient-focused-drug-development-selecting-developing-or-modifying-fit-for-purpose-clinical-outcome-assessments/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in September 2022 about Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments can be found below.
- [Protection of Human Subjects and Institutional Review Boards – Proposed Rule](https://www.acrohealth.org/resource/protection-of-human-subjects-and-institutional-review-boards-proposed-rule/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in November 2022 about Protection of Human Subjects and Institutional Review Boards – Proposed Rule can be found below.
- [Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials](https://www.acrohealth.org/resource/diversity-plans-to-improve-enrollment-of-participants-from-underrepresented-racial-and-ethnic-populations-in-clinical-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in June 2022 about Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials can be found below.
- [House Energy & Commerce Subcommittee on Health Hearing on “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight”](https://www.acrohealth.org/resource/house-energy-commerce-subcommittee-on-health-hearing-on-the-future-of-medicine-legislation-to-encourage-innovation-and-improve-oversight/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in March 2022 about the House Energy & Commerce Subcommittee on Health Hearing on “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight”.
- [Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities](https://www.acrohealth.org/resource/remote-interactive-evaluations-of-drug-manufacturing-and-bioresearch-monitoring-facilities/)
- [FTC Commercial Surveillance ANPRM](https://www.acrohealth.org/resource/ftc-commercial-surveillance-anprm/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FTC in November 2022 about FTC Commercial Surveillance ANPRM can be found below.
- [Frequently Asked Questions — Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards](https://www.acrohealth.org/resource/frequently-asked-questions-statement-of-investigator-form-fda-1572-revision-1-draft-information-sheet-guidance-for-sponsors-clinical-investigators-and-institutional-review-boards/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in July 2021 about Frequently Asked Questions — Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards can be
- [Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry](https://www.acrohealth.org/resource/conducting-remote-regulatory-assessments-questions-and-answers-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in September 2022 about Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry can be found below.
- [21st Century Cures Act 2.0 Discussion Draft](https://www.acrohealth.org/resource/21st-century-cures-act-2-0-discussion-draft/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to the U.S. Congress in July 2021 about the 21st Century Cures Act 2.0 Discussion Draft.
- [Risk-based Monitoring in Clinical Trials: Past, Present & Future](https://www.acrohealth.org/resource/rbqmlandscape/) - ACRO’s RBQM report shows how clinical trials were forced to shift to remote monitoring during the COVID-19 pandemic, and highlights why the industry shouldn’t turn back. Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand the RBM implementation
- [Considerations to Support Clinical Trial Monitoring Oversight During COVID-19](https://www.acrohealth.org/resource/considerations-to-support-clinical-trial-monitoring-oversight-during-covid-19/) - The emerging coronavirus (COVID-19) situation is increasingly impacting clinical trial oversight, particularly on-site monitoring. The Association of Clinical Research Organizations (ACRO) recommends that sponsors, CROs and sites introduce emergency interim measures so that clinical trial monitoring is maintained during this period. These guidelines will ensure that data quality is unaffected, clinical trial sites are supported
- [Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight](https://www.acrohealth.org/resource/risk-based-quality-management-rbqm-a-collaborative-approach-to-holistic-clinical-trial-oversight/) - ACRO and CRO Forum’s paper enables greater collaboration and efficiency through a shared vision of risk-based quality management (RBQM). Collaboration is key. ACRO’s cross-company team of subject matter experts share perspectives that will help sponsor organizations create an RBQM system in partnership with CROs and technology vendors. When sponsors, CROs, and vendors can work from
- [Provisions Pertaining to Preventing Access to Americans' Bulk Sensitive Personal Data and U.S. Government-Related Data by Countries of Concern](https://www.acrohealth.org/resource/provisions-pertaining-to-preventing-access-to-americans-bulk-sensitive-personal-data-and-u-s-government-related-data-by-countries-of-concern/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to DOJ in April 2024 about Preventing Access to Americans' Bulk Sensitive Personal Data and U.S. Government-Related Data by Countries of Concern.
- [Enhancing Adoption of Innovative Clinical Trial Approaches](https://www.acrohealth.org/resource/enhancing-adoption-of-innovative-clinical-trial-approaches/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2024 about Enhancing Adoption of Innovative Clinical Trial Approaches can be found below.
- [Conducting Remote Regulatory Assessments—Questions and Answers; Revised Draft Guidance for Industry](https://www.acrohealth.org/resource/conducting-remote-regulatory-assessments-questions-and-answers-revised-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2024 about Conducting Remote Regulatory Assessments can be found below.
- [Navigating Change During Rapid Transformation: A Q&A Resource for Decentralized Clinical Trials](https://www.acrohealth.org/resource/navigating-change-during-rapid-transformation-a-qa-resource-for-decentralized-clinical-trials/) - Stakeholders are experiencing a paradigm shift in the clinical trial enterprise from conventional trials to studies where at least one or more DCT components are utilized (e.g., direct-to-patient shipment and home health visits). The use of DCT components is here to stay, and stakeholders need the tools to successfully embrace this change. While the Quality-by-Design
- [ACRO’s Quality By-Design Manual for Decentralized Trials](https://www.acrohealth.org/resource/acros-quality-by-design-manual-for-decentralized-trials/) - Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials The Quality-by-Design Manual for Decentralized Clinical Trials provides guiding principles and risk considerations at each step in the construction of a decentralized clinical trial.
- [ACRO Artificial Intelligence & Machine Learning Principles Statement](https://www.acrohealth.org/resource/acro-artificial-intelligence-machine-learning-principles-statement/) - ACRO’s Artificial Intelligence/Machine Learning Committee produced the following Principles Statement in December 2023. The committee represents the industry to regulators and policymakers considering regulation and legislation that could impact the use of AI/ML in drug development.
- [Template for Risk Assessment Considerations](https://www.acrohealth.org/resource/dctqbdmanual/) - Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials The DCT Risk Considerations tool is designed to complement an organization’s current risk assessment tools. It provides questions, considerations, and potential mitigations to facilitate a quality-by-design and risk management approach to decentralized trial design.
- [QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide](https://www.acrohealth.org/resource/qbdguide/) - The QbD Manual Quick Reference Guide was created to provide a more readily accessible and easily digestible version of the full-length ACRO DCT QbD Manual.
- [Decentralizing Clinical Trials: The White Paper](https://www.acrohealth.org/resource/dctwhitepaper/) - ACRO DCT White Paper: A New Quality-by-Design, Risk-Based Framework ACRO’s DCT White Paper provides an overview of considerations for decentralized clinical trials and introduces the Quality-by-Design Manual and Risk-Assessment Template.
- [Decentralized Clinical Trials Data Flow Maps](https://www.acrohealth.org/resource/dctdataflow/) - Data integrity and data quality are key pillars of clinical research. The ACRO DCT Data Flow Maps are designed to build confidence and trust in decentralized clinical trials by providing transparency and visibility into data flow, data controls, and data traceability within a DCT to illustrate how a decentralized model guards data quality and integrity.
- [Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020](https://www.acrohealth.org/resource/rbqmincreasedadoption/) - ACRO’s RBQM report provides a comprehensive update on the RBM implementation landscape, using the results of ACRO’s latest 2020 landscape survey results. With the emergence of new technologies for data collection, the continued impact of the COVID-19 pandemic, and the increasing number of partially or fully decentralized clinical trials (DCTs), the importance of risk-based monitoring
- [Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies](https://www.acrohealth.org/resource/establishing-risk-based-monitoring-within-a-quality-based-system-as-best-practice-for-clinical-studies/) - A 2019 survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. Risk-Based Monitoring (RBM) makes an impact. The 2019 paperreport, Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies, found that when a company reviews data through a centralized system using the RBM
- [INFOGRAPHIC: Data Quality and Patient Safety](https://www.acrohealth.org/wp-content/uploads/2023/11/ACRO-RBM-Insights-June-2019.pdf)
- [The Risk-Based Monitoring Landscape in 2018](http://The Risk-Based Monitoring Landscape in 2018)
- [ACRO Comments on FDA Guidance](https://www.acrohealth.org/wp-content/uploads/2019/07/ACRO-Comment-FDA-RBM-2016-05.pdf)
- [WEBINAR SERIES: How much do you know about Risk-Based Monitoring (RBM)?](https://www.acrohealth.org/risk-based-monitoring-webinar-series-a-clinical-trial-odyssey/)
- [ACRO Op Ed in Pharma Letter: Realizing the promise of decentralized trials](https://www.thepharmaletter.com/article/realizing-the-promise-of-decentralized-clinical-trials#new_tab)
- [Proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation](https://www.acrohealth.org/resource/proposed-base-erosion-and-anti-abuse-tax-beat-regulation/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to URS in 2019 about Proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation can be found below.
- [How much do you know about Risk-Based Monitoring (RBM)](https://www.acrohealth.org/resource/risk-based-monitoring-webinar-series-a-clinical-trial-odyssey/) - View the slides for Module 1. Module 2: What Could Go Wrong? ICH E6 R2, Investigative Sites and Risk Assessment View the slides for Module 2. Module 3: What’s Behind the Curtain? Centralized Monitoring Unveiled View the slides for Module 3. Module 4: An Exploration of Risk Based Monitoring from the Site Perspective View the slides for Module 4.
- [RBQM Trial Evaluation](https://www.acrohealth.org/resource/rbqm-trial-evaluation/) - ACRO members have made significant investments to advance RBM. From reshaping and bolstering their workforce to support this growth to developing diverse, cross-functional solutions, to incorporating new and updated methods to support and improve RBM across clinical research.
- [Risk-Based Monitoring in Clinical Trials: 2021 Update](https://www.acrohealth.org/resource/rbqm-2021-update/) - A Survey of ACRO Member Companies Shows How Risk-Based Approaches Are Used in Clinical Trials In early 2022, ACRO conducted the third consecutive year of its annual landscape survey, and this report highlights key findings. The aim of the survey is to answer ACRO member companies’ and global regulators’ interest in understanding how risk-based monitoring
- [Federal Policy for the Protection of Human Subjects](https://www.acrohealth.org/resource/federal-policy-for-the-protection-of-human-subjects/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to OHRP in 2015 about Federal Policy for the Protection of Human Subjects can be found below.
- [Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research](https://www.acrohealth.org/resource/draft-nih-policy-on-the-use-of-a-single-institutional-review-board-for-multi-site-research/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to NIH in 2015 about Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research can be found below.
- [Comments on proposed regulations implementing IRC section 59A (IRS REG-104259-18)](https://www.acrohealth.org/resource/comments-on-proposed-regulations-implementing-irc-section-59a-irs-reg-104259-18/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to IRS in 2019 about Comments on proposed regulations implementing IRC section 59A (IRS REG-104259-18) can be found below.
- [Request for Information, RIN 0945-AA00 – HIPAA Rules and recommendation to facilitate the use of PHI for essential research](https://www.acrohealth.org/resource/request-for-information-rin-0945-aa00-hipaa-rules-and-recommendation-to-facilitate-the-use-of-phi-for-essential-research/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to HHS and OCR in 2019 about Request for Information, RIN 0945-AA00 – HIPAA Rules and recommendation to facilitate the use of PHI for essential research can be found below.
- [Comments for the November 23, 2020, Centers for Disease Control and Prevention Advisory Committee on Immunization Practices Meeting](https://www.acrohealth.org/resource/comments-for-the-november-23-2020-centers-for-disease-control-and-prevention-advisory-committee-on-immunization-practices-meeting/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to CDC in 2020 about Comments for the November 23, 2020, Centers for Disease Control and Prevention Advisory Committee on Immunization Practices Meeting can be found below.
- [Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors – Draft Guidance](https://www.acrohealth.org/resource/informed-consent-information-sheet-guidance-for-institutional-review-boards-clinical-investigators-and-sponsors-draft-guidance/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2014 about Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors – Draft Guidance can be found below.
- [Notice of Proposed Rulemaking regarding Clinical Trials Registration and Results Submission](https://www.acrohealth.org/resource/notice-of-proposed-rulemaking-regarding-clinical-trials-registration-and-results-submission/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2015 about Notice of Proposed Rulemaking regarding Clinical Trials Registration and Results Submission can be found below.
- [Clinical Trial Imaging Endpoint Process Standards – Draft Guidance for Industry](https://www.acrohealth.org/resource/clinical-trial-imaging-endpoint-process-standards-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2015 about Clinical Trial Imaging Endpoint Process Standards – Draft Guidance for Industry can be found below.
- [Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data](https://www.acrohealth.org/resource/source-data-capture-from-electronic-health-records-using-standardized-clinical-research-data/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2015 about Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data can be found below.
- [Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers – Draft Guidance](https://www.acrohealth.org/resource/use-of-electronic-informed-consent-in-clinical-investigations-questions-and-answers-draft-guidance/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2015 about Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers – Draft Guidance can be found below.
- [Docket No. FDA–2015–N–3579: Using Technologies and Innovative Methods to Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs](https://www.acrohealth.org/resource/docket-no-fda-2015-n-3579-using-technologies-and-innovative-methods-to-conduct-food-and-drug-administration-regulated-clinical-investigations-of-investigational-drugs/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2016 about Docket No. FDA–2015–N–3579: Using Technologies and Innovative Methods to Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs can be found below.
- [Use of Electronic Health Record Data in Clinical Investigations – Draft Guidance](https://www.acrohealth.org/resource/use-of-electronic-health-record-data-in-clinical-investigations-draft-guidance/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2016 about Use of Electronic Health Record Data in Clinical Investigations – Draft Guidance can be found below.
- [Enhancing Patient Engagement Efforts across FDA](https://www.acrohealth.org/resource/enhancing-patient-engagement-efforts-across-fda/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2017 about Enhancing Patient Engagement Efforts across FDA can be found below.
- [Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry – Draft Guidance](https://www.acrohealth.org/resource/use-of-electronic-records-and-electronic-signatures-in-clinical-investigations-under-21-cfr-part-11-questions-and-answers-guidance-for-industry-draft-guidance/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2017 about Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry – Draft Guidance can be
- [Multiple Endpoints in Clinical Trials; Draft Guidance for Industry](https://www.acrohealth.org/resource/multiple-endpoints-in-clinical-trials-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2017 about Multiple Endpoints in Clinical Trials; Draft Guidance for Industry can be found below.
- [Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics](https://www.acrohealth.org/resource/master-protocols-efficient-clinical-trial-design-strategies-to-expedite-development-of-oncology-drugs-and-biologics/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2018 about Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics can be found below.
- [Adaptive Designs for Clinical Trials of Drugs and Biologics](https://www.acrohealth.org/resource/adaptive-designs-for-clinical-trials-of-drugs-and-biologics/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2018 about Adaptive Designs for Clinical Trials of Drugs and Biologics can be found below.
- [FDA Draft Guidance for industry: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics](https://www.acrohealth.org/resource/fda-draft-guidance-for-industry-expansion-cohorts-use-in-first-in-human-clinical-trials-to-expedite-development-of-oncology-drugs-and-biologics/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2018 about FDA Draft Guidance for industry: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics can be found below.
- [Docket No. FDA-2018-D-1893-0002, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input”](https://www.acrohealth.org/resource/docket-no-fda-2018-d-1893-0002-patient-focused-drug-development-collecting-comprehensive-and-representative-input/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2018 about Docket No. FDA-2018-D-1893-0002, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input” can be found below.
- [Pediatric Rare Diseases—A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry](https://www.acrohealth.org/resource/pediatric-rare-diseases-a-collaborative-approach-for-drug-development-using-gaucher-disease-as-a-model-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2018 about Pediatric Rare Diseases—A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry can be found below.
- [Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics](https://www.acrohealth.org/resource/submitting-documents-using-real-world-data-and-real-world-evidence-to-the-food-and-drug-administration-for-drugs-and-biologics/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2019 about Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics can be found below.
- [Docket No. FDA–2018–N–2727 – FDA Proposed Rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (21 CFR Parts 50, 312, and 812)](https://www.acrohealth.org/resource/docket-no-fda-2018-n-2727-fda-proposed-rule-on-institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical-investigations-21-cfr-p/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2019 about Docket No. FDA–2018–N–2727 – FDA Proposed Rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (21 CFR Parts 50, 312,
- [Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products](https://www.acrohealth.org/resource/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory-decision-making-for-drug-and-biological-products/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2021 about Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products can be found below.
- [International Council for Harmonisation (ICH) Draft Guidance for Industry: Q9(R1) Quality Risk Management](https://www.acrohealth.org/resource/international-council-for-harmonisation-ich-draft-guidance-for-industry-q9r1-quality-risk-management/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2022 about International Council for Harmonisation (ICH) Draft Guidance for Industry: Q9(R1) Quality Risk Management can be found below.
- [Real-World Data: Assessing Registries To Support Regulatory Decision-making for Drug and Biological Products](https://www.acrohealth.org/resource/real-world-data-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological-products/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2022 about Real-World Data: Assessing Registries To Support Regulatory Decision-making for Drug and Biological Products can be found below.
- [Considerations for the Use of Real-world Data and Real-World Evidence To Support Regulatory Decision-making for Drug and Biological Products](https://www.acrohealth.org/resource/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory-decision-making-for-drug-and-biological-products/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2022 about Considerations for the Use of Real-world Data and Real-World Evidence To Support Regulatory Decision-making for Drug and Biological Products can be found below.
- [Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A for Industry](https://www.acrohealth.org/resource/electronic-systems-electronic-records-and-electronic-signatures-in-clinical-investigations-qa-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A for Industry can be found below.
- [Considerations for the Design and Conduct of Externally Controlled Trials](https://www.acrohealth.org/resource/considerations-for-the-design-and-conduct-of-externally-controlled-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Considerations for the Design and Conduct of Externally Controlled Trials can be found below.
- [Framework for the Use of Digital Health Technologies in Drug and Biological Product Development](https://www.acrohealth.org/resource/framework-for-the-use-of-digital-health-technologies-in-drug-and-biological-product-development/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Framework for the Use of Digital Health Technologies in Drug and Biological Product Development can be found below.
- [Decentralized Clinical Trials for Drugs, Biological Products, and Devices](https://www.acrohealth.org/resource/decentralized-clinical-trials-for-drugs-biological-products-and-devices/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Decentralized Clinical Trials for Drugs, Biological Products, and Devices can be found below.
- [Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products](https://www.acrohealth.org/resource/using-artificial-intelligence-and-machine-learning-in-the-development-of-drug-and-biological-products-2/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products can be found below.
- [Postmarketing Approaches to Obtain Data on Underrepresented Populations](https://www.acrohealth.org/resource/postmarketing-approaches-to-obtain-data-on-underrepresented-populations/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about Postmarketing Approaches to Obtain Data on Underrepresented Populations can be found below.
- [Summary of Clinical Trial Results for Laypersons](https://www.acrohealth.org/resource/summary-of-clinical-trial-results-for-laypersons/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EU>European Commission in 2016 about Summary of Clinical Trial Results for Laypersons can be found below.
- [E6(R3) Good Clinical Practice (GCP) Guideline](https://www.acrohealth.org/resource/e6r3-good-clinical-practice-gcp-guideline/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2023 about E6(R3) Good Clinical Practice (GCP) Guideline can be found below.
- [NCATS RFI: Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials](https://www.acrohealth.org/resource/ncats-rfi-advancing-clinical-and-translational-science-through-accelerating-the-decentralization-of-clinical-trials/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to NIH in 2023 about NCATS RFI: Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials can be found below.
- [Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry](https://www.acrohealth.org/resource/ethical-considerations-for-clinical-investigations-of-medical-products-involving-children-draft-guidance-for-industry/) - As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2022 about Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry can be found below.
- [ACRO Policy Recommendations for Guidance on Electronic Systems and Electronic Data in Clinical Trials](https://www.acrohealth.org/resource/acro-policy-recommendations-for-guidance-on-electronic-systems-and-electronic-data-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about ACRO Policy Recommendations for Guidance on Electronic Systems and Electronic Data in Clinical Trials can be found below.
- [Supplemental comment on European Commission Consultation on the Revision of the General Pharmaceutical Legislation](https://www.acrohealth.org/resource/supplemental-comment-on-european-commission-consultation-on-the-revision-of-the-general-pharmaceutical-legislation/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2021 about Supplemental comment on European Commission Consultation on the Revision of the General Pharmaceutical Legislation can be found below.
- [Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 rev. 2 corrigendum)](https://www.acrohealth.org/resource/requirements-for-quality-documentation-concerning-biological-investigational-medicinal-products-in-clinical-trials-ema-chmp-bwp-534898-2008-rev-2-corrigendum/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 rev. 2 corrigendum) can be found below.
- [Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/31884/2021)](https://www.acrohealth.org/resource/requirements-to-the-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-in-clinical-trials-ema-chmp-qwp-31884-2021/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/31884/2021) can be found below.
- [Comment on EMA Draft Guideline on Computerised Systems and Electronic Data in Clinical Trials (EMA/226170/2021)](https://www.acrohealth.org/resource/comment-on-ema-draft-guideline-on-computerised-systems-and-electronic-data-in-clinical-trials-ema-226170-2021/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2021 about Comment on EMA Draft Guideline on Computerised Systems and Electronic Data in Clinical Trials (EMA/226170/2021) can be found below.
- [EMA Draft Guidance on the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the CTIS (EMA/212507/2021)](https://www.acrohealth.org/resource/ema-draft-guidance-on-the-protection-of-personal-data-and-commercially-confidential-information-in-documents-uploaded-and-published-in-the-ctis-ema-212507-2021/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2022 about EMA Draft Guidance on the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the CTIS (EMA/212507/2021) can be found below.
- [Public Consultation Concerning the Physical Attendance and the Location Of Personal Residency of the Qualified Person (EMA/INS/169000/2022)](https://www.acrohealth.org/resource/public-consultation-concerning-the-physical-attendance-and-the-location-of-personal-residency-of-the-qualified-person-ema-ins-169000-2022/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2022 about Public Consultation Concerning the Physical Attendance and the Location Of Personal Residency of the Qualified Person (EMA/INS/169000/2022) can be found below.
- [ICH M11 Clinical Electronic Structured Harmonised Protocol – Guideline](https://www.acrohealth.org/resource/ich-m11-clinical-electronic-structured-harmonised-protocol-guideline/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2023 about ICH M11 Clinical Electronic Structured Harmonised Protocol – Guideline can be found below.
- [ICH M11 Clinical Electronic Structured Harmonised Protocol – Template](https://www.acrohealth.org/resource/ich-m11-clinical-electronic-structured-harmonised-protocol-template/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2023 about ICH M11 Clinical Electronic Structured Harmonised Protocol – Template can be found below.
- [ICH Reflection Paper on Harmonization of RWE Terminology](https://www.acrohealth.org/resource/ich-reflection-paper-on-harmonization-of-rwe-terminology/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2023 about ICH Reflection Paper on Harmonization of RWE Terminology can be found below.
- [Multi-Stakeholder Request to Prioritize IVDR/CTR interface under ACT-EU](https://www.acrohealth.org/resource/multi-stakeholder-request-to-prioritize-ivdr-ctr-interface-under-act-eu/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2023 about Multi-Stakeholder Request to Prioritize IVDR/CTR interface under ACT-EU can be found below.
- [Supplemental Statement on the Draft EHDS Regulation (May 2023)](https://www.acrohealth.org/resource/supplemental-statement-on-the-draft-ehds-regulation-may-2023/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to Europeah Health Data Space (EHDS) in 2023 about Supplemental Statement on the Draft EHDS Regulation (May 2023) can be found below.
- [Multi-stakeholder open letter expressing concerns regarding the impact of IVDR implementation on patient access to clinical trials](https://www.acrohealth.org/resource/multi-stakeholder-open-letter-expressing-concerns-regarding-the-impact-of-ivdr-implementation-on-patient-access-to-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2023 about Multi-stakeholder open letter expressing concerns regarding the impact of IVDR implementation on patient access to clinical trials can be found below.
- [European Commission Survey on ACT EU Agenda and Priorities](https://www.acrohealth.org/resource/european-commission-survey-on-act-eu-agenda-and-priorities/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2023 about European Commission Survey on ACT EU Agenda and Priorities can be found below.
- [Multi-Stakeholder Recommendations for transitioning Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation](https://www.acrohealth.org/resource/multi-stakeholder-recommendations-for-transitioning-clinical-trials-from-the-clinical-trials-directive-to-the-clinical-trials-regulation/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2023 about Multi-Stakeholder Recommendations for transitioning Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation can be found below.
- [2023 Survey on the Implementation of the Clinical Trials Regulation](https://www.acrohealth.org/resource/2023-survey-on-the-implementation-of-the-clinical-trials-regulation/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2023 about 2023 Survey on the Implementation of the Clinical Trials Regulation can be found below.
- [ACRO Request for Clarification of ‘Health Institution’ Definition in IVDR Regulation](https://www.acrohealth.org/resource/acro-request-for-clarification-of-health-institution-definition-in-ivdr-regulation/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2023 about ACRO Request for Clarification of ‘Health Institution’ Definition in IVDR Regulation can be found below.
- [ACRO Recommendations to Independent Review of the State of Commercial Clinical Trials in the UK](https://www.acrohealth.org/resource/acro-recommendations-to-independent-review-of-the-state-of-commercial-clinical-trials-in-the-uk/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to United Kingdom in 2023 about ACRO Recommendations to Independent Review of the State of Commercial Clinical Trials in the UK can be found below.
- [ACRO Policy Recommendations Letter, Submitted to Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, in follow up to 24 October Clinical Research Roundtable](https://www.acrohealth.org/resource/acro-policy-recommendations-letter-submitted-to-lord-oshaughnessy-parliamentary-under-secretary-of-state-for-health-in-follow-up-to-24-october-clinical-research-roundtable/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK Department of Health in 2018 about ACRO Policy Recommendations Letter, Submitted to Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, in follow up to 24 October Clinical Research Roundtable can be
- [House of Commons Health and Social Care Committee Inquiry: Impact of a No Deal Brexit on Health and Social Care](https://www.acrohealth.org/resource/house-of-commons-health-and-social-care-committee-inquiry-impact-of-a-no-deal-brexit-on-health-and-social-care/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK House of Commons in 2018 about House of Commons Health and Social Care Committee Inquiry: Impact of a No Deal Brexit on Health and Social Care can be found below.
- [European Commission consultation: Good Clinical Practice (GCP) for advanced therapy medicinal products (ATMPs)](https://www.acrohealth.org/resource/european-commission-consultation-good-clinical-practice-gcp-for-advanced-therapy-medicinal-products-atmps/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2018 about European Commission consultation: Good Clinical Practice (GCP) for advanced therapy medicinal products (ATMPs) can be found below.
- [Comments on Article 29 Working Party Guidelines on Transparency under the GDPR (WP260)](https://www.acrohealth.org/resource/comments-on-article-29-working-party-guidelines-on-transparency-under-the-gdpr-wp260/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to Article 29 Data Protection Working Party in 2018 about Comments on Article 29 Working Party Guidelines on Transparency under the GDPR (WP260) can be found below.
- [EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)](https://www.acrohealth.org/resource/ema-draft-addendum-to-the-guideline-on-the-evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections-to-address-paediatric-specific-clinical-data-requirements-ema-chmp-187859-2/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017) can be found below.
- [Concept paper: Preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections](https://www.acrohealth.org/resource/concept-paper-preparation-of-a-revised-guideline-on-the-evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about Concept paper: Preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections can be found below.
- [Draft Guideline: Responsibilities of the sponsor: Handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice](https://www.acrohealth.org/resource/draft-guideline-responsibilities-of-the-sponsor-handling-and-shipping-of-investigational-medicinal-products-for-human-use-in-accordance-with-good-clinical-practice-and-good-manufacturing-practice/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about Draft Guideline: Responsibilities of the sponsor: Handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice can be found
- [EMA Draft reflection paper: Investigation of pharmacokinetics and pharmacodynamics in the obese population](https://www.acrohealth.org/resource/ema-draft-reflection-paper-investigation-of-pharmacokinetics-and-pharmacodynamics-in-the-obese-population/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about EMA Draft reflection paper: Investigation of pharmacokinetics and pharmacodynamics in the obese population can be found below.
- [ICH E9 (R1) addendum: Estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017)](https://www.acrohealth.org/resource/ich-e9-r1-addendum-estimands-and-sensitivity-analysis-in-clinical-trials-to-the-guideline-on-statistical-principles-for-clinical-trials-ema-chmp-ich-436221-2017/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about ICH E9 (R1) addendum: Estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017) can be found below.
- [EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1)](https://www.acrohealth.org/resource/ema-draft-revision-guideline-on-safety-and-efficacy-follow-up-and-risk-management-of-advanced-therapy-medicinal-products-emea-149995-2008-rev-1/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1) can be found below.
- [House of Commons Science and Technology Committee: Brexit, Science and Innovation: Preparations for ‘No-Deal’ inquiry](https://www.acrohealth.org/resource/house-of-commons-science-and-technology-committee-brexit-science-and-innovation-preparations-for-no-deal-inquiry/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK House of Commons in 2019 about House of Commons Science and Technology Committee: Brexit, Science and Innovation: Preparations for ‘No-Deal’ inquiry can be found below.
- [Comments on draft Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019)](https://www.acrohealth.org/resource/comments-on-draft-guideline-on-the-quality-requirements-for-drug-device-combinations-ema-chmp-qwp-bwp-259165-2019/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2019 about Comments on draft Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019) can be found below.
- [Public consultation on EMA Regulatory Science to 2025 (EMA online survey)](https://www.acrohealth.org/resource/public-consultation-on-ema-regulatory-science-to-2025-ema-online-survey/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2019 about Public consultation on EMA Regulatory Science to 2025 (EMA online survey) can be found below.
- [Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3](https://www.acrohealth.org/resource/guideline-on-the-evaluation-of-medicinal-products-indicated-for-treatment-of-bacterial-infections-rev-3/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2019 about Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3 can be found below.
- [Comments on eSource Direct Data Capture (DDC) qualification opinion (EMA/282576/2018)](https://www.acrohealth.org/resource/comments-on-esource-direct-data-capture-ddc-qualification-opinion-ema-282576-2018/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2019 about Comments on eSource Direct Data Capture (DDC) qualification opinion (EMA/282576/2018) can be found below.
- [European Medicines Agencies Network Strategy to 2025](https://www.acrohealth.org/resource/european-medicines-agencies-network-strategy-to-2025/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2020 about European Medicines Agencies Network Strategy to 2025 can be found below.
- [EMA Draft Guidance on Points to Consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (EMA/158330/2020) Joint Industry Comment Letter from EFPIA, ACRO, EuropaBio, Vaccines Europe, EFSPI, and EUCROF](https://www.acrohealth.org/resource/ema-draft-guidance-on-points-to-consider-on-implications-of-coronavirus-disease-covid-19-on-methodological-aspects-of-ongoing-clinical-trials-ema-158330-2020-joint-industry-comment-letter-from-efp/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2020 about EMA Draft Guidance on Points to Consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (EMA/158330/2020) Joint Industry Comment Letter from EFPIA, ACRO, EuropaBio,
- [Feedback on Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020)](https://www.acrohealth.org/resource/feedback-on-guidance-on-the-management-of-clinical-trials-during-the-covid-19-coronavirus-pandemic-version-2-27-03-2020/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2020 about Feedback on Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020) can be found below.
- [The General Data Protection Regulation (GDPR) Secondary Use of Health Data for Medicines and Public Health Purposes (16/07/20)](https://www.acrohealth.org/resource/the-general-data-protection-regulation-gdpr-secondary-use-of-health-data-for-medicines-and-public-health-purposes-16-07-20/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2020 about The General Data Protection Regulation (GDPR) Secondary Use of Health Data for Medicines and Public Health Purposes (16/07/20) can be found below.
- [The use of rSDV and the recent guidance on the management of clinical trials during the COVID-19 pandemic (15/09/20)](https://www.acrohealth.org/resource/the-use-of-rsdv-and-the-recent-guidance-on-the-management-of-clinical-trials-during-the-covid-19-pandemic-15-09-20/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2020 about The use of rSDV and the recent guidance on the management of clinical trials during the COVID-19 pandemic (15/09/20) can be found below.
- [Ethical considerations for clinical trials on medicinal products conducted with minors](https://www.acrohealth.org/resource/ethical-considerations-for-clinical-trials-on-medicinal-products-conducted-with-minors/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2016 about Ethical considerations for clinical trials on medicinal products conducted with minors can be found below.
- [Draft Guideline: Requirements for quality documentation concerning biological investigational medicinal products in clinical trials](https://www.acrohealth.org/resource/draft-guideline-requirements-for-quality-documentation-concerning-biological-investigational-medicinal-products-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guideline: Requirements for quality documentation concerning biological investigational medicinal products in clinical trials can be found below.
- [Guideline: Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials](https://www.acrohealth.org/resource/guideline-requirements-to-the-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Guideline: Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials can be found below.
- [Concept paper: Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products](https://www.acrohealth.org/resource/concept-paper-strategies-to-identify-and-mitigate-risks-for-first-in-human-clinical-trials-with-investigational-medicinal-products/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Concept paper: Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products can be found below.
- [Draft Guidance: Format of the risk management plan (RMP) in the EU – in integrated format (Rev2)](https://www.acrohealth.org/resource/draft-guidance-format-of-the-risk-management-plan-rmp-in-the-eu-in-integrated-format-rev2/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guidance: Format of the risk management plan (RMP) in the EU – in integrated format (Rev2) can be found below.
- [Reflection paper: The use of extrapolation in the development of medicines for paediatrics](https://www.acrohealth.org/resource/reflection-paper-the-use-of-extrapolation-in-the-development-of-medicines-for-paediatrics/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Reflection paper: The use of extrapolation in the development of medicines for paediatrics can be found below.
- [Draft Guidance: Good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2)](https://www.acrohealth.org/resource/draft-guidance-good-pharmacovigilance-practices-gvp-module-v-risk-management-systems-rev-2/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guidance: Good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2) can be found below.
- [Draft Guidance: Post-authorisation efficacy studies](https://www.acrohealth.org/resource/draft-guidance-post-authorisation-efficacy-studies/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2016 about Draft Guidance: Post-authorisation efficacy studies can be found below.
- [Brexit – medicines, medical devices and substances of human origin inquiry – Regulatory arrangements needed to guarantee safe and effective supply of medicines, medical devices and products post-Brexit](https://www.acrohealth.org/resource/brexit-medicines-medical-devices-and-substances-of-human-origin-inquiry-regulatory-arrangements-needed-to-guarantee-safe-and-effective-supply-of-medicines-medical-devices-and-pro/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK House of Commons in 2017 about Brexit – medicines, medical devices and substances of human origin inquiry – Regulatory arrangements needed to guarantee safe and effective supply of medicines, medical devices and
- [Reflection paper: Good Clinical Practice (GCP) “Renovation”](https://www.acrohealth.org/resource/reflection-paper-good-clinical-practice-gcp-renovation/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2017 about Reflection paper: Good Clinical Practice (GCP) “Renovation” can be found below.
- [ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b](https://www.acrohealth.org/resource/ich-e11r1-guideline-on-clinical-investigation-of-medicinal-products-in-the-pediatric-population-step-2b/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2017 about ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b can be found below.
- [Concept paper: Predictive biomarker-based assay development in the context of drug development and lifecycle](https://www.acrohealth.org/resource/concept-paper-predictive-biomarker-based-assay-development-in-the-context-of-drug-development-and-lifecycle/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Concept paper: Predictive biomarker-based assay development in the context of drug development and lifecycle can be found below.
- [Concept paper: Revision of the guideline on clinical development of vaccines](https://www.acrohealth.org/resource/concept-paper-revision-of-the-guideline-on-clinical-development-of-vaccines/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Concept paper: Revision of the guideline on clinical development of vaccines can be found below.
- [Draft guideline: Notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol](https://www.acrohealth.org/resource/draft-guideline-notification-of-serious-breaches-of-regulation-eu-no-536-2014-or-the-clinical-trial-protocol/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Draft guideline: Notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol can be found below.
- [Concept paper: Revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population](https://www.acrohealth.org/resource/concept-paper-revision-of-the-guideline-on-the-role-of-pharmacokinetics-in-the-development-of-medicinal-products-in-the-paediatric-population/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Concept paper: Revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population can be found below.
- [Concept paper: Guideline on the evaluation of medicinal products indicated for treatment of influenza](https://www.acrohealth.org/resource/concept-paper-guideline-on-the-evaluation-of-medicinal-products-indicated-for-treatment-of-influenza/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Concept paper: Guideline on the evaluation of medicinal products indicated for treatment of influenza can be found below.
- [Draft guideline: Good clinical practice compliance in relation to trial master file (TMF) for content, management, archiving, audit and inspection of clinical trials](https://www.acrohealth.org/resource/draft-guideline-good-clinical-practice-compliance-in-relation-to-trial-master-file-tmf-for-content-management-archiving-audit-and-inspection-of-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Draft guideline: Good clinical practice compliance in relation to trial master file (TMF) for content, management, archiving, audit and inspection of clinical trials can be found below.
- [EMA draft guideline: Multiplicity issues in clinical trials](https://www.acrohealth.org/resource/ema-draft-guideline-multiplicity-issues-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about EMA draft guideline: Multiplicity issues in clinical trials can be found below.
- [Guideline on Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products](https://www.acrohealth.org/resource/guideline-on-strategies-to-identify-and-mitigate-risks-for-first-in-human-and-early-clinical-trials-with-investigational-medicinal-products/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2017 about Guideline on Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products can be found below.
- [MHRA consultation on EU exit no-deal legislative proposals – ACRO response to Clinical Trials Section only](https://www.acrohealth.org/resource/mhra-consultation-on-eu-exit-no-deal-legislative-proposals-acro-response-to-clinical-trials-section-only/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK MHRA in 2018 about MHRA consultation on EU exit no-deal legislative proposals – ACRO response to Clinical Trials Section only can be found below.
- [UK policy framework for health and social care research – Version 1.0 (February 2015) – HRA 2015 informal request for comments, preceding formal public consultation period in 2016](https://www.acrohealth.org/resource/uk-policy-framework-for-health-and-social-care-research-version-1-0-february-2015-hra-2015-informal-request-for-comments-preceding-formal-public-consultation-period-in-2016/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK HRA in 2015 about UK policy framework for health and social care research – Version 1.0 (February 2015) – HRA 2015 informal request for comments, preceding formal public consultation period in 2016
- [Public consultation on detailed arrangements for clinical trial inspection procedures including the qualification and training requirements for inspectors pursuant to Article 78(7) of Regulation (EU) No 536/2014](https://www.acrohealth.org/resource/public-consultation-on-detailed-arrangements-for-clinical-trial-inspection-procedures-including-the-qualification-and-training-requirements-for-inspectors-pursuant-to-article-787-of-regulation-eu/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2015 about Public consultation on detailed arrangements for clinical trial inspection procedures including the qualification and training requirements for inspectors pursuant to Article 78(7) of Regulation (EU) No 536/2014 can
- [Commission Guidelines: Good manufacturing practice for investigational medicinal products, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014](https://www.acrohealth.org/resource/commission-guidelines-good-manufacturing-practice-for-investigational-medicinal-products-pursuant-to-the-second-subparagraph-of-article-631-of-regulation-eu-no-536-2014/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2015 about Commission Guidelines: Good manufacturing practice for investigational medicinal products, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014 can be found below.
- [Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014](https://www.acrohealth.org/resource/commission-delegated-act-on-principles-and-guidelines-on-good-manufacturing-practice-for-investigational-medicinal-products-and-on-inspection-procedures-pursuant-to-the-first-subparagraph-of-article/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2015 about Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of
- [Draft proposal for an addendum to the Functional specifications for the EU portal and EU database to be audited](https://www.acrohealth.org/resource/draft-proposal-for-an-addendum-to-the-functional-specifications-for-the-eu-portal-and-eu-database-to-be-audited/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about Draft proposal for an addendum to the Functional specifications for the EU portal and EU database to be audited can be found below.
- [EU Telematics Strategy and Implementation Roadmap 2015-2017](https://www.acrohealth.org/resource/eu-telematics-strategy-and-implementation-roadmap-2015-2017/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about EU Telematics Strategy and Implementation Roadmap 2015-2017 can be found below.
- [EU Medicines Agencies Network Strategy to 2020 – Working together to improve health](https://www.acrohealth.org/resource/eu-medicines-agencies-network-strategy-to-2020-working-together-to-improve-health/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about EU Medicines Agencies Network Strategy to 2020 – Working together to improve health can be found below.
- [Concept paper: Revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials](https://www.acrohealth.org/resource/concept-paper-revision-of-the-guideline-on-the-requirements-to-the-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about Concept paper: Revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials can be found below.
- [GVP Module VIII – Post-authorisation safety studies (Rev 2)](https://www.acrohealth.org/resource/gvp-module-viii-post-authorisation-safety-studies-rev-2/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about GVP Module VIII – Post-authorisation safety studies (Rev 2) can be found below.
- [GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev 2)](https://www.acrohealth.org/resource/gvp-module-viii-addendum-i-requirements-for-transmission-of-information-on-non-interventional-post-authorisation-safety-studies-rev-2/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev 2) can be found below.
- [Guidance on the procedural aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA policy 0070](https://www.acrohealth.org/resource/guidance-on-the-procedural-aspects-related-to-the-submission-of-clinical-reports-for-the-purpose-of-publication-in-accordance-with-ema-policy-0070/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2015 about Guidance on the procedural aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA policy 0070 can be found below.
- [Inquiry on Leaving the EU: Implications and Opportunities for Science and Research](https://www.acrohealth.org/resource/inquiry-on-leaving-the-eu-implications-and-opportunities-for-science-and-research/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK House of Commons in 2016 about Inquiry on Leaving the EU: Implications and Opportunities for Science and Research can be found below.
- [MHRA GxP Data Integrity Definitions and Guidance for Industry](https://www.acrohealth.org/resource/mhra-gxp-data-integrity-definitions-and-guidance-for-industry/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to UK MHRA in 2016 about MHRA GxP Data Integrity Definitions and Guidance for Industry can be found below.
- [ICH E17 General Priniciples for Planning and Design of Multi-Regional Clinical Trials](https://www.acrohealth.org/resource/ich-e17-general-priniciples-for-planning-and-design-of-multi-regional-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2016 about ICH E17 General Priniciples for Planning and Design of Multi-Regional Clinical Trials can be found below.
- [ICH Guideline E18 on genomic sampling and management of genomic data](https://www.acrohealth.org/resource/ich-guideline-e18-on-genomic-sampling-and-management-of-genomic-data/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2016 about ICH Guideline E18 on genomic sampling and management of genomic data can be found below.
- [E6(R2) Integrated Addendum: Good Clinical Practice](https://www.acrohealth.org/resource/e6r2-integrated-addendum-good-clinical-practice/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to ICH in 2016 about E6(R2) Integrated Addendum: Good Clinical Practice can be found below.
- [Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)](https://www.acrohealth.org/resource/definition-of-investigational-medicinal-products-imps-and-use-of-auxiliary-medicinal-products-amps/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2016 about Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) can be found below.
- [Risk Proportionate approaches in clinical trials](https://www.acrohealth.org/resource/risk-proportionate-approaches-in-clinical-trials/) - As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to European Commission in 2016 about Risk Proportionate approaches in clinical trials can be found below.

## Categories

- [Press Releases](https://www.acrohealth.org/category/press-releases/)
- [News](https://www.acrohealth.org/category/news/)
- [Lessons Learned](https://www.acrohealth.org/category/lessons-learned/)
- [Reports](https://www.acrohealth.org/category/reports/)
- [COVID-19](https://www.acrohealth.org/category/covid-19/)
- [Members Hub](https://www.acrohealth.org/category/members-hub/)
- [DEI](https://www.acrohealth.org/category/members-hub/dei/)
- [COVID -19](https://www.acrohealth.org/category/members-hub/covid-19-members-hub/)
- [Technical Innovation](https://www.acrohealth.org/category/members-hub/technical-innovation/)
- [Risk-Based Monitoring](https://www.acrohealth.org/category/members-hub/risk-based-monitoring/)
- [Real-World Evidence](https://www.acrohealth.org/category/members-hub/real-world-evidence/)
- [Decentralized Trials](https://www.acrohealth.org/category/members-hub/decentralized-trials/)

## Tags

- [Brexit|UK](https://www.acrohealth.org/tag/brexituk/)
- [Brexit|policy|UK](https://www.acrohealth.org/tag/brexitpolicyuk/)
- [Brexit|MP|UK](https://www.acrohealth.org/tag/brexitmpuk/)
- [Compassionate Use|Congress|House|Right-To-Try|Senate](https://www.acrohealth.org/tag/compassionate-usecongresshouseright-to-trysenate/)
- [Duke University|FDA|recruitment](https://www.acrohealth.org/tag/duke-universityfdarecruitment/)
- [Board of Directors|IQVIA|Syneos Health](https://www.acrohealth.org/tag/board-of-directorsiqviasyneos-health/)
- [Clinical Trial Regulation|digital|EU](https://www.acrohealth.org/tag/clinical-trial-regulationdigitaleu/)
- [BEAT|IRS|Testimony|Treasury](https://www.acrohealth.org/tag/beatirstestimonytreasury/)
- [ERT|IQVIA|membership|Oracle|Veeva](https://www.acrohealth.org/tag/ertiqviamembershiporacleveeva/)
- [digital|FDA|oversight|RBM|Risk Based Montoring](https://www.acrohealth.org/tag/digitalfdaoversightrbmrisk-based-montoring/)
- [FDA|RBM|Risk Based Montoring](https://www.acrohealth.org/tag/fdarbmrisk-based-montoring/)
- [decentralized trials|Parexel|remote monitoring](https://www.acrohealth.org/tag/decentralized-trialsparexelremote-monitoring/)
- [patient access|Real World Data|Real World Evidence|RWD](https://www.acrohealth.org/tag/patient-accessreal-world-datareal-world-evidencerwd/)
- [collaboration|cycle times|technology](https://www.acrohealth.org/tag/collaborationcycle-timestechnology/)
- [eConsent|technology](https://www.acrohealth.org/tag/econsenttechnology/)
- [decentralized trials|Oracle](https://www.acrohealth.org/tag/decentralized-trialsoracle/)
- [IQVIA|RBM|remote monitoring](https://www.acrohealth.org/tag/iqviarbmremote-monitoring/)
- [close out|IQVIA|remote monitoring](https://www.acrohealth.org/tag/close-outiqviaremote-monitoring/)
- [Parexel|Real World Evidence|synthetic control arm|tokenizing data](https://www.acrohealth.org/tag/parexelreal-world-evidencesynthetic-control-armtokenizing-data/)
- [IQVIA|patient access|remote monitoring|trial continuity](https://www.acrohealth.org/tag/iqviapatient-accessremote-monitoringtrial-continuity/)
- [eCOA|Signant|vaccine](https://www.acrohealth.org/tag/ecoasignantvaccine/)

## Advocacy Initiative

- [Advocacy](https://www.acrohealth.org/advocacy-initiative/advocacy/)
- [Initiative](https://www.acrohealth.org/advocacy-initiative/initiative/)

## Content Types

- [Perspective](https://www.acrohealth.org/content-type/perspective/)
- [Case Study](https://www.acrohealth.org/content-type/case-study/)
- [Grantee Spotlight](https://www.acrohealth.org/content-type/grantee-spotlight/)
- [Good Clinical Podcast](https://www.acrohealth.org/content-type/good-clinical-podcast/)
- [Podcast Deep Dive](https://www.acrohealth.org/content-type/podcast-deep-dive/)
- [Event Recap](https://www.acrohealth.org/content-type/event-recap/)
- [Industry Voice](https://www.acrohealth.org/content-type/industry-voice/)

## Members Categories

- [Member](https://www.acrohealth.org/members-category/member/)
- [Associate Member](https://www.acrohealth.org/members-category/associate-member/)
- [D&I Grant Site](https://www.acrohealth.org/members-category/di-grant-site/)

## People Category

- [ACRO Staff](https://www.acrohealth.org/people-category/acro-staff/)
- [Board Member](https://www.acrohealth.org/people-category/board-member/)
- [Officer](https://www.acrohealth.org/people-category/officer/)

## Resource Body

- [US](https://www.acrohealth.org/resource-body/us/)
- [FDA](https://www.acrohealth.org/resource-body/fda/)
- [NIH](https://www.acrohealth.org/resource-body/nih/)
- [FTC](https://www.acrohealth.org/resource-body/ftc/)
- [CDC](https://www.acrohealth.org/resource-body/cdc/)
- [HHS](https://www.acrohealth.org/resource-body/hhs/)
- [IRS](https://www.acrohealth.org/resource-body/irs/)
- [OHRP](https://www.acrohealth.org/resource-body/ohrp/)
- [EU](https://www.acrohealth.org/resource-body/eu/)
- [United Kingdom](https://www.acrohealth.org/resource-body/united-kingdom/)
- [European Commission](https://www.acrohealth.org/resource-body/european-commission/)
- [Europeah Health Data Space (EHDS)](https://www.acrohealth.org/resource-body/europeah-health-data-space-ehds/)
- [EMA](https://www.acrohealth.org/resource-body/ema-eu/)
- [ICH](https://www.acrohealth.org/resource-body/ich/)
- [European Data Protection Board](https://www.acrohealth.org/resource-body/european-data-protection-board/)
- [UK House of Commons](https://www.acrohealth.org/resource-body/uk-house-of-commons/)
- [Article 29 Data Protection Working Party](https://www.acrohealth.org/resource-body/article-29-data-protection-working-party/)
- [UK Department of Health](https://www.acrohealth.org/resource-body/uk-department-of-health/)
- [UK MHRA](https://www.acrohealth.org/resource-body/uk-mhra/)
- [UK HRA](https://www.acrohealth.org/resource-body/uk-hra/)
- [DOJ](https://www.acrohealth.org/resource-body/doj/)
- [U.S. Congress](https://www.acrohealth.org/resource-body/u-s-congress/)
- [OSTP](https://www.acrohealth.org/resource-body/ostp/)

## Resource Category

- [Decentralized Trials](https://www.acrohealth.org/resource-category/decentralized-trials/)
- [Risk-Based Management](https://www.acrohealth.org/resource-category/risk-based-management/)
- [AI/ML](https://www.acrohealth.org/resource-category/ai-ml/)
- [Interpreting ICH E6(R3)](https://www.acrohealth.org/resource-category/interpreting-ich-e6r3/)
- [Global Data Protection & Privacy](https://www.acrohealth.org/resource-category/gdpp/)

## Resource Type

- [Infographic](https://www.acrohealth.org/resource-type/infographic/)
- [Webinar Series](https://www.acrohealth.org/resource-type/webinar-series/)
- [White Paper](https://www.acrohealth.org/resource-type/white-paper/)
- [Report](https://www.acrohealth.org/resource-type/report/)
- [Comment Letter](https://www.acrohealth.org/resource-type/comment-letter/)
- [Statement](https://www.acrohealth.org/resource-type/statement/)
- [Statement for the Record](https://www.acrohealth.org/resource-type/statement-for-the-record/)
- [Press Release](https://www.acrohealth.org/resource-type/press-release/)

## Topics

- [Regulatory](https://www.acrohealth.org/topic/regulatory/)
- [Policy & Legislation](https://www.acrohealth.org/topic/policy-legislation/)
- [Access & Representation](https://www.acrohealth.org/topic/access-representation/)
- [RBQM](https://www.acrohealth.org/topic/rbqm/)
- [Global Impact](https://www.acrohealth.org/topic/global-impact/)
- [Sustainability](https://www.acrohealth.org/topic/sustainability/)
- [AI & Technology](https://www.acrohealth.org/topic/ai-technology/)
- [Patient Centricity](https://www.acrohealth.org/topic/patient-centricity/)
- [Data Privacy](https://www.acrohealth.org/topic/data-privacy/)