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…
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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…
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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.
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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.
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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.
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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…
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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.
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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,…
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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…
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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…
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Who’s in and who’s out? ACRO talks 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,…
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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…
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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,…
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John Ratliff of 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…
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ACRO Urges Modernization of the R&D Tax Credit
WASHINGTON – November 14, 2017 – As the Senate begins debate on a tax reform bill, the clinical research industry hopes that…
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ACRO Testifies About Clinical Trials In New Jersey
Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of…
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Majority of Americans Open to Clinical Trial Participation If Recommended by a 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….
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Right to 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…
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ACRO Strongly Endorses Domestic Research Enhancement Act of 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…
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Dear Director Collins and Director Brennan
February 21, 2017 Dr. Francis S. Collins Director, National Institutes of Health Dr. Patricia Flatley Brennan Director, National Library of Medicine Re:…