COVID-19Lessons Learned

A new fight sees new tools and new challenges

November 2, 2020

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.

COVID-19Lessons Learned

When technology may be the easy part

October 26, 2020

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?

COVID-19Lessons Learned

A global sense of urgency: Collaborating to advance the conduct of clinical trials

October 23, 2020

“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.

COVID-19Lessons Learned

The need for new paradigms

October 21, 2020

“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.

COVID-19Lessons Learned

A Catalyst for Innovation, Urgency for Now, Momentum for the Future

October 19, 2020

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.

Lessons Learned

Sharpening the pencil: Rethinking trial design with the patient at the center

October 15, 2020

New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a…

Lessons Learned

Patient engagement, thinking ahead and how the clinical research industry helps solve global problems: A conversation with Alistair Macdonald – Part 2

October 9, 2020

In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In…

Lessons Learned

Clinical Research in the COVID Era: Learning Lessons, Saving Lives

September 29, 2020

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.

Lessons Learned

COVID, the role of digital, and the future of clinical research: A conversation with Alistair Macdonald – Part 1

September 29, 2020

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.

Press Releases

New ACRO Report Introduces Quality-by-Design, Risk-Based Framework for Decentralizing Clinical Trials

September 1, 2020

September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This…

NewsPress Releases

ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic

May 6, 2020

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research…

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News

2020 Officers and New Member Announcement

December 17, 2019

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair…

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News

ACRO hosts Congressional Briefing on clinical research advancements

October 24, 2019

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development…

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NewsReports

A Consistent Approach to Risk Based Quality Management: Collaboration is Key

October 24, 2019

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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NewsReports

New ACRO Report Quantifies Benefits of RBM for Quality Reviews

October 17, 2019

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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News

Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials

August 16, 2019

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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NewsPress Releases

ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

May 16, 2019

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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NewsPress Releases

ACRO expands membership with addition of three digital technology companies

April 15, 2019

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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News

ACRO testifies before IRS and Treasury Department on proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation

March 29, 2019

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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News

EU efforts turn towards digital for 2019

February 27, 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.