Trial Master File Management

Uphold Documentation Processes to Safeguard Good Clinical Practices

Trial Master File Management

$995.00

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

 

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REPORT VITALS AND FEATURES 

This report examines existing trial master file practices, such as the scope of teams’ involvement, best practices for trial master file (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
Report Features

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 trial master files groups. trial master files 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.

Reason to Buy

Develop trial master file milestones to ensure timely document submissions. The trial master file'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.

Keep pace with industry trends around eTMFs. 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.

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

Chapter Example

Throughout the course of its study, Cutting Edge Information found that life sciences companies are increasing the percentage of electronic documents included in their trial master files. Moreover, surveyed teams project this trend to continue within the next three to five years. Examining this trend across teams with global, US and other country-level responsibilities shows that:
• Surveyed global teams estimate that an average of 54% of their TMFs are electronic (Figure E.1). By comparison, the same teams expect this balance to shift to 88% by 2020.
• US teams plan to increase their percentage of electronic documents from 38% to 76% from 2015 to 2020.
• Country-level teams in the developed markets of the EU anticipate increasing from 45% to 77%.
• Country-level teams in emerging markets anticipate undergoing the most dramatic change. On average, surveyed teams in Brazil and India plan to increase their distribution of electronic and paper documents from 8% and 92% to 77% and 23%, respectively.