The rising value of Clinical Monitoring Oversight
The Clinical Monitoring Oversight landscape has changed dramatically. New strategies and processes are required due to rapid technology adoption accelerated by the pandemic, as well as new regulatory guidance driving quality cultures that prioritizes proper oversight. As a sponsor, you are increasingly responsible for the integrity of all activity and data generated by your third-party vendors. The question many sponsors now face is: how do we adapt our approach to properly oversee the activities and ensure the quality of our CRO’s work?
John R. Wilson, Jr., Ph.D., Beaufort’s SVP and Chief Quality Officer addressed these pressing issues at the 2nd Annual Clinical Quality Oversight conference. Dr. Wilson is an industry leader in Clinical Monitoring Oversight and Beaufort was proud to sponsor this important event to share our proven approach to helping sponsors effectively protect the integrity and safety of their clinical trial.
Ensure Clinical Trial Integrity, Patient Safety and Regulatory Conformity Right from the Start
Dr. Wilson’s presentation covered the following topics:
- The new landscape of Clinical Monitoring Oversight for sponsors
- FDA guidance on CRO oversight and the importance of risk-based monitoring
- Reinforcing a culture of quality through comprehensive oversight planning
- The core elements of effective Clinical Monitoring Oversight
- Understanding the blind spots sponsors risk with a data-only approach to Clinical Monitoring Oversight
- The impact of on-site oversight monitoring on end of trial reporting and readiness
- The tangible benefits of comprehensive Clinical Monitoring Oversight
Beaufort has decades of experience providing leading health science companies with Clinical Monitoring Oversight. Our proven process helps proactively assess CRA and site performance, ensure participant safety, maintain data integrity, and demonstrate to regulatory bodies that your trial meets the highest scientific, ethical, and regulatory standards.
Learn more about Beaufort’s Clinical Monitoring Oversight