The ICH E6(R3) Guideline introduces a modernized framework for Good Clinical Practice (GCP), emphasizing flexibility, proportionality, and quality-by-design to better support diverse clinical trial models and evolving technologies.
Written by Health Canada The International Council for Harmonization (ICH) E6(R3) Guideline, finalized in January 2025, represents a significant evolution in the global standards for Good Clinical Practice (GCP). The Guideline builds upon previous versions by integrating lessons learned from decades of clinical research and addressing the rapid transformation in trial methodologies, digital technologies, and […]
Ontario’s Universal Agreement for Clinical Trials: New Partners, New Version
One Year Later In the fall of 2024, Ontario made history by launching a universal agreement for clinical trials (known as the UACT or the “U-ACT”), which serves as a pre-negotiated contract between research institutions and sponsors for industry-funded clinical trials. Led by the Ontario Leadership Table for Clinical Trials and Clinical Trials Ontario (CTO), […]