Navigating The Latest ICH E8(R1) Guideline Revisions: Best Practices For Application With Increased Trial Variabilities

By Sue Batchelor, Director, Clinical Operations and Delivery at Cmed

Here, we outline the key principles set forth in E8(R1), which was endorsed in May, 2019, and E6(R3), which is scheduled for publication in late 2022, illustrating how Sponsors and Contract Research Organizations (CROs) can achieve compliance.

Cmed has been operating at the highest clinical research standards for over 20 years. Our established change management processes enable us to incorporate industry advances thoroughly and maintaining our trusted provider status. Therefore, we recommend undertaking a holistic review of internal processes to ensure they’re proactive in their intent and capable of accommodating current and future trial variabilities. When selecting their CRO partners, Sponsors should take the time to understand the CRO’s approach to development, planning, and trial conduct. Ideally, the CRO will pursue a cycle of continuous improvement in quality study management that includes proactive and reactive approaches to traceability, accountability, and data integrity.