JULY 2023LIFE SCIENCES REVIEW8IN MY OPINIONrial master files were long treated as an archive repository for all documents related to a clinical trial. That approach doesn't properly reflect the evolving story of a study, which will go through a variety of changes and milestones throughout the product lifecycle and across different study regions. While regulatory authorities have guidelines around the management of the TMF, this alone does not ensure inspection readiness. To achieve completeness, timeliness and quality with the TMF there is a need for technology that can support the evolving story at any point along the way, and which, at the same time, is easy to use and integrates with other systems. Although there is general recognition in the post-pandemic world that electronic is a necessity for the TMF, many solutions either lack the sophistication needed to support both the study evolution and, most critically, achieve inspection-readiness or require huge manual effort. PharmaLex recognized the challenges faced by our customers and saw the need for a fit-for-purpose TMF solution that would deliver a complete, high-quality set of documentation. With this realization, PharmaLex acquired TMF leader Phlexglobal to help companies get into and stay in the TMF health zone, which means completeness, timeliness, and quality. Making your eTMF inspection-readyRegulatory authorities, including the FDA, have been increasing their scrutiny of the TMF and tightening reinforcement. Inspection reports have uncovered numerous critical findings related to record-keeping, usually due to incomplete TMFs or poor-quality documentation, inadequate oversight and control of the study and TMF, and lack of compliance or documentation missing from the TMF.A fit-for-purpose eTMF solution that is not restricted by limitations of the document management platform that a sponsor or contract research organization (CRO) has in place is critical. Such a solution overcomes the challenges of feeding data into the eTMF from clinical trial management systems and study start-up systems by connecting into those platforms and taking data from those systems to ensure a complete, high-quality set of documentation.In so doing, companies can be assured of an accurate and complete audit trail of their documentation and proper management of documents across various sections of the TMF, ensuring the eTMF is inspection-ready.By Susan K. Maue, Managing Director, PharmaLexACHIEVING TRIAL MASTER FILE QUALITY, TIMELINESS AND COMPLETENESSTAddressing data transferabilityOne of the big challenges in study close-out is transferring the TMF from the CRO to the sponsor. Additionally, these documents remain crucial well after a study ends and after this transfer, and must be readily available for inspection.With robust fit-for-purpose software, CROs can package the sponsor's eTMF and very simply transfer it into another system. This mid-term, pre-archival configuration allows the eTMF to be stored in an inspection-ready state, allowing inspectors to access the eTMF directly online. Such transferability should be aligned with the global standards development organization, CDISC, which announced official affiliation with the Trial Master File (TMF) Reference Model Group in April 2022. To support the exchange of TMF content and create commonality
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