An effective electronic Trial Master File (eTMF) is vital to the product development and approval process, serving as the cornerstone for clinical trial inspections by regulatory authorities. It contains the essential records needed to confirm a trial’s compliance with regulatory standards and Good Clinical Practice (GCP).
Successfully implementing and managing an eTMF requires strategic planning, strong governance, and a deep understanding of regulatory requirements. Avoid common challenges and ensure long-term success with our comprehensive guide.
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