NOVEMBER 20249TECH OUTLOOKExecutive buy-in is one of the biggest barriers for companies trying to adopt a comprehensive eTMF solution. There has to be a top-down organizational commitment so all functional groups involved with the study makes it their objective to contribute to a complete, high-quality eTMFAddressing 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 bealigned 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 across platforms, a sub-group from the TMF Reference Model developed an eTMF Exchange Mechanism Standard (EMS). Importantly, Phlex TMF supports the EMS, removing the need for convoluted mapping and manipulation when transferring the TMF between stakeholders. "Having a standardized TMF structure for all documents from all studies across companiesradically streamlines any document and data transfer required," says Karen Roy, senior VP of clinical marketing at PharmaLex Company, Phlexglobal, and Chair of the TMF Reference Model Steering Committee. "Now that we are a part of CDISC, the TMF Reference Model becoming a standard will enforce this standardization"People, Process, and TechnologyOne of the biggest differentiators between the PharmaLex approach to eTMF and other solutions is the flexible and adaptable design that lets clients simply license the technology and run it themselves, buy a service where PharmaLex sets up the technology, deploys it and delivers the service, or a hybrid of the two where PharmaLex helps with some parts of the process. This approach offers the triple benefit of people, process and technology. The technology, or solutions aspect, refers to having a fit-for-purpose eTMF solution that ensuresthe TMF is complete, of good quality, enables proper oversight and provides a complete and clear audit trail for inspectors.For the eTMF technology to attain the goal of achieving the TMF health zone, it also needs to be underpinned by people and processes, which can be delivered through deploying PharmaLex's services. This delivers guidance from experts in TMF best practices, regulatory standards as well as the technology itself to improve productivity, efficiency and quality. It also ensures expert processing services to achieve completeness, timeliness and quality of the TMF at every stage of the study. (See graphic below)Keys to successful management of the TMF include:· Have staff dedicated to the TMF· Ensure in-house TMF experience and expertise for internal TMF management as well as CRO oversight· Provide comprehensive and regular training on SOPs, TMF technology and document management processes· Stay current on the latest regulatory guidance related to the TMF· Identify barriers affecting collaboration with internal and external teams working on the TMF· Ensure SOPs are aligned with requirements and ensure all stakeholders interpret SOPs the same way· Conduct regular internal TMF audits and site audits· Obtain executive buy-in on the importance of the TMFThe last point, executive buy-in, is one of the biggest barriers for companies trying to adopt a comprehensive eTMF solution. There has to be a top-down organizational commitment so all functional groups involved with the study makes it their objective to contribute to a complete, high-quality eTMF. As a company committed to helping sponsors and CROs achieve this objective through our technology and services, PharmaLex can help to address the compliance challenges that have proven to be an ongoing issue for companies.
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