Trial Master File Setup

A high-quality Trial Master File is critical to the success of a trial as it is the tool used to demonstrate compliance and allows for verification of the integrity of the trial data and patient safety. With this in mind, an inspection-ready TMF is the goal of all clinical research.

FCR is adept at implementing Trial Master File setup to ensure the system of record for all content is complete and accurate. We will create a master reference document and ensure a thorough master list of possible content to file in the TMF. We offer TMF training to stakeholders to ensure the integrity of the TMF, and perform maintenance to ensure the documentation filed meets quality criteria throughout the life of the clinical trial.

We can also create a customized process for collecting documentation from clinical sites and functional lines to facilitate the process during study start-up, study execution, and study close-out.

We deploy a quality control process to ensure that the TMF is complete, accurate and inspection-ready at all times. At closeout, we perform final remediation to ensure that any discrepancies have been resolved and that the TMF is properly closed and archived.

Contact us to learn more about our TMF services.

Review of all TMF Documents
Trial Management
Central Trial Documents
IRB/IEC & other Approvals
Site Management
IP and Trial Supplies
Safety Reporting
Central and Local Testing
Third Parties
Data Management