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Effective Trial Master File (TMF) management is essential for maintaining compliance, supporting smooth clinical trial operations, and ensuring ongoing inspection readiness. A well-managed TMF not only meets regulatory requirements but also strengthens collaboration across teams and reduces operational risk. Whether you're just beginning your TMF journey or are a seasoned professional looking to enhance existing practices, implementing proven strategies can make a significant impact.
These 15 expert-recommended approaches offer a comprehensive guide to help you build a strong TMF foundation, improve document quality and organization, and achieve long-term efficiency across your clinical trial workflows.