Phlexglobal - The Trial Master File (TMF) Experts, are pioneers in the provision of innovative, flexible and technology-enabled TMF solutions & services.
Phlexglobal is a worldwide leader and specialist in the provision of electronic Trial Master File (eTMF) document management solutions as well as all associated TMF support services. We offer a unique combination of Task Force support, TMF and eTMF systems and Quality Control services that deliver solutions to the pharmaceutical, biotechnology, medical device, CRO and lifescience industries. Phlexglobal counts 17 of the top 20 global pharmaceutical companies amongst its clients.
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PhlexEview is Phlexglobal’s electronic Trial Master File (eTMF) system allowing centralized viewing and review of the TMF across the internet. Our associated business processing service enables the production of a regulatory compliant eTMF in accordance with MHRA, EMA & FDA - 21 CFR part 11 requirements.
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TMF Reference Model
The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a TMF. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed by a team of volunteers encompassing more than 165 companies.
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