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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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