January 2025 – On January 6, 2025, the ICH-GCP E6(R3) guideline reached Step 4, marking its finalization. It now awaits implementation across all ICH regions. This new guidance represents a comprehensive revision of the previous version, introducing significant updates to enhance the quality and flexibility of clinical trials. It emphasizes the “Fit for Purpose” concept, a proportionate approach to quality, and data reliability. The guideline also supports innovation and the use of technological advancements in clinical trials.
CROSS welcomes this important milestone in clinical research and has already proactively initiated processes to adopt and implement the new paradigms. Our team is fully committed and ready to guide your trials through the challenges of these new requirements, ensuring a smooth transition and continued success in your Clinical Research.