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Site Readiness Under ICH E6(R3): Key Guidance for Sponsors
Discover how the finalized ICH E6(R3) guideline elevates site and sponsor collaboration, emphasizing robust training, resource allocation, and digitally empowered data governance. This concise article outlines critical updates, from risk-based monitoring to formalized documentation, ensuring your clinical trial operations align with leading edge GCP requirements and maintain the highest standards of patient safety and data integrity.