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 evaluates adoption levels to improve our understanding of how RBQM is being utilized by sponsors and CROs across the clinical trial industry. Critically, the data highlights the progress made in phasing out traditional trials and shows the challenges in adopting complete, holistic risk-based approaches.
As an extension of ACRO’s presentation, we also shared two case studies on the benefits of centralized monitoring. The two case studies we shared demonstrate how centralized monitoring was used to identify otherwise undetected equipment malfunctions at one site and found that underqualified individuals were taking measurements at another site. In both instances, centralized monitoring picked up quality issues that would have gone undetected with traditional on-site monitoring. The ACRO team has pulled together an entire series of case studies, Centralized Monitoring at Work, and will be rolling them out on the ACRO website over the next few weeks.
The presentation was followed by robust discussion touching on the remaining barriers to centralized monitoring adoption and quality oversight in ICH E6(R3), including perceived fear and caution around inspections and more. This session continued an important conversation between regulators and the clinical research community and provided us with the opportunity to make the agency aware of several continuing pinch points when it comes to fuller adoption of centralized monitoring and other aspects of RBQM. The agency acknowledged these challenges and emphasized that, in order to reduce anxiety and fear associated with risk-based monitoring, RBQM needs to be understood as a part of a Quality-by-Design (QbD) approach to clinical trials.
Meeting with our U.S. regulatory bodies is an important part of the public policy process, and it impacts everything we do in our industry. We appreciate the FDA continuing to have dialogue with ACRO around issues impacting clinical trials and research.
We were thrilled to have in attendance the following valued leaders from our RBQM Committee (Pictured Left to Right): Shailesh Madel of ICON, Andrea Bastek of Florence, Rachael Fones of IQVIA, Nicole Stansbury of Premier Research, Cris McDavid of Parexel, and Amy Kroeplin of PPD/ThermoFisher.
If you’d like more information about ACRO’s recent RBQM landscape survey, please visit: https://lnkd.in/eBjmg7Na.