Trial Master File Management


Use this study to examine existing TMF practices, such as the scope of teams’ involvement, best practices for TMF oversight and quality control activities and companies’ transition from paper-based to eTMF platforms.

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This report examines existing TMF practices, such as the scope of teams’ involvement, best practices for TMF oversight and quality control activities and companies’ transitions from paper-based to eTMF platforms including:

  • Pilot programs and timing of planned electronic transitions
  • Which documents (if any) remain paper
  • How companies may work with clinical storage warehouses to facilitate the transition between paper and electronic files

Data have been split by team region:

  • Global
  • US
  • Country-Level

Data have also been split by company size:

  • Top 10
  • Top 50
  • Small
  • Device

Top Reasons to Read This Trial Master File Management Report

CREATE STANDARD OPERATING PROCEDURES TO GUIDE QUALITY CONTROL EFFORTS BEFORE FINALIZING TRIAL MASTER FILES: Standard operating procedures are essential to successful quality control systems within TMF groups. TMFs contain a wide array of materials — all of which need to be kept up-to-date, accurate and complete. SOPs ensure that quality control stakeholders have evaluated an adequate number of documents in advance of regulatory audits or inspections. Use Trial Master File Management to encourage timely document submissions and ease the burden for the document storage and archiving groups.

DEVELOP TMF MILESTONES TO ENSURE TIMELY DOCUMENT SUBMISSIONS: The TMF’s goal is to archive a clinical trial’s story in real time — meaning that groups submit documents as soon as they are ready. While this goal sounds simple enough, clinical groups sometimes delay TMF submissions because they are preoccupied with other trial activities. Investigator sites — which are responsible for a large portion of TMF documents — often prioritize collecting and managing data over paperwork. Use this report to develop milestones in the TMF SOPs that ensure timely document submissions.

CONVERT PAPER TMF DOCUMENTS INTO ELECTRONIC FORMATS TO KEEP PACE WITH INDUSTRY PROJECTIONS: Life science companies are increasing the percentage of electronic documents included in their TMF files. Moreover, surveyed teams project this trend to continue within the next three to five years. Consider implementing electronic platforms to reduce the amount of paper storage needed, increase teamwide accessibility to essential materials, and reduce inspection challenges. This report investigates the type of eTMF solution preferred by surveyed teams with electronic trial master files; the initial costs associated with eTMF solutions, by team; the average projected distribution of electronic and paper-based TMF documents and more.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource

Examples of companies that have participated in this study:

Trial Master File Management Study Participation List