Webinar: Do You Have an Effective Oversight Plan of Your CRO-Vendor? How Are You Measuring It? ICH E6 R2 Requirements for Vendor Oversight

Recorded Wednesday, January 29, 2020  |  11:00am – 12:00pm EST

Sponsor Responsibilities for Quality Management (Section 5.0 of ICH E6 (R2)) requires that Sponsors oversee trial-related duties and functions, including those that are subcontracted by CROs (5.2.2). Quality assurance has changed from assurance of conformity to the assurance that process performance and quality are managed over the (relationship and) trial life cycle. Focusing monitoring and oversight resources on risks that matter has become an obligation.

Key Takeaways:

1. Risk-based monitoring is just one component of risk management activities.
2. Value is derived from using risk management in the prevention of issues related to human subject protection and reliability of clinical trial results.
3. Risk Management programs require a structure to support repeatability but need to be flexible enough to adapt to the various situations that may arise.

Brigid Flanagan is a research professional with 20+ years in clinical operations. In her role as Senior Consultant for The Avoca Group, Brigid provides input on operational plans, vendor qualification, and oversight for pharmaceutical clients conducting trials in the US and EU. She is passionate about research and the benefits it offers to participants. Brigid has been an active member of ACRP since 1998 and most recently was Vice Chair of their Professional Ethics Committee. She has an undergraduate degree in Sociology, trained as an RN in the UK, and completed a Masters in Bioethics at Union Graduate College/Mount Sinai School of Medicine in New York, NY.