JULY 2023LIFE SCIENCES REVIEW9across platforms, a sub-group from the TMF Reference Model developed an eTMF Exchange Mechanism Standard (EMS). Importantly, PhlexTMF 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 companies radically 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. 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 ensures the 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 make 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. 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
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