Implementing ICH E6 (R2) and
Planning for E6 (R3):
Lessons Learned from a CRO Perspective
This white paper describes lessons learned during the organizational implementation of E6 (R2) at Advanced Clinical, examining operational hurdles and solutions, examples of how E6 R2 was implemented in active clinical studies, and the resulting QRM structure and auxiliary processes. The paper will also consider takeaways from this experience that can be applied during future regulatory updates such as E6 (R3).