Becoming fully compliant with the latest and soon-to-be released ICH E8(R1) guidance documents and subsequent E6(R3) revision is a necessary journey, but what are the recommended next steps for sponsors? In this insightful white paper, we outline the key principles set forth in E8(R1) and reveal intelligent approaches for applying the guidelines.
You will learn:
- The evolution of the guidelines
- A holistic approach to efficacy guidance
- How to choose the right CRO partner to reap the benefits of working under these guidelines
