Sponsor

Feb 2025

Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

By |2025-02-26T22:37:15+02:00February 26, 2025|Blog, Free Infographics, News, Resources|Comments Off on 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.

Sep 2024

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

By |2024-11-25T19:43:54+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).

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