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.
“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.
“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.
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.
New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a…
In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In…
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.
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.
September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This…
May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research…
Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair…
On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development…
Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to…
A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient…
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.
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.
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.
On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department…
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.