Trial Master File Benchmarking Data

Trial Master File Benchmarking Data


Cutting Edge Information surveyed clinical research and development executives involved with or with knowledge of their companies trial master file (TMF) operations. The following charts present trial master file benchmarking data collected from more than 60 TMF executives around the world.

  • Description
  • Additional information

The trial master file benchmarking data in this document will show you how companies organize their TMFs marks to make difference between a successful and less-than-successful regulatory audit. A recent EMA paper highlighted the more common pitfalls companies experience when managing their TMF documents. Problematic audit findings often center on the TMF structure, including:

  • Key documents missing, such as SOP-related materials or those outlining breakdown of sponsor and CRO responsibilities
  • Unnecessarily repeated documents
  • Improper or inconsistent indexing in which either provided links did not yield the appropriate document or sponsor teams were unable to direct regulators to requested materials

Consistent quality control procedures can resolve many of the aforementioned problems that emerge during regulatory inspections.  This data packet will provide you key trial master file benchmarking data that will guide your TMF processes and resources.

Report Features

Guide quality control efforts before finalizing trial master files. TMFs contain a wide array of materials — all of which need to be kept up-to-date, accurate and complete. Use the trial master file benchmarking data in this file to create SOPs to ensure quality control in advance of regulatory audits or inspections. Use Trial Master File Benchmarking Data to develop metrics around document submissions and ease the burden for the document storage and archiving groups.

Reason to Buy

Compare trial master file benchmarking data to develop milestones for document submissions.  Clinical groups sometimes delay TMF submissions because they are preoccupied with other trial activities.  Use this trial master file benchmarking analysis to find out the key milestones for submitting TMF documents.

Keep Pace with Industry Projections for Electronic TMF documentation. What percentage of your TMF documents are stored electronically?  This trial master file benchmarking analysis 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.

Target Audience

Boipharmaceutical executives in the following functions will find the benchmarks and best practices in this study beneficial to making strategic decisions around trial master files:
– Clinical development/operations
– Clinical trial management
– Regulatory affairs
– Clinical quality assurance
– Clinical quality control