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September 30, 2025

ICH GCP E6(R3) Guidance Flyer

The International Council for Harmonisation (ICH) has released the new Good Clinical Practice (GCP) E6(R3) guidelines, effective July 25, 2025. These updates set a global standard for ethical, scientific, and quality practices in clinical trials to protect participant rights and improve outcomes.
Key Highlights:
  • Advanced data governance and transparency
  • Risk-based quality management
  • Digital and AI-enabled insights
  • Flexible, patient-centric trial designs
  • Broader stakeholder collaboration
  • Strategic feasibility and trial planning

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