8 NOVEMBER 2024TECH OUTLOOKIN MY OPINIONACHIEVING TRIAL MASTER FILE QUALITY, TIMELINESS AND COMPLETENESSBy Susan K. Maue, Managing Director, US and Puerto Rico, PharmaLexTrial master files were long treated as an archive repository for all documents related to a clinical trial. That approach does not 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-readinessor require huge manual effort.PharmaLex recognized the challenges faced by our customersand 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.Susan K. Maue
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