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Phlexglobal to Improve eTMF Document Transfers with Adoption of New Exchange Mechanism Standard

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Phlexglobal, a specialist provider of technology-enabled Trial Master File (TMF & eTMF) management solutions, is adopting Version 1 of the eTMF Exchange Mechanism Standard (eTMF-EMS) of the TMF Reference Model (TMF-RM) into PhlexEview, the company’s eTMF technology. This marks a major advancement in efficient document interchange and will firmly solidify Phlexglobal’s position as a driving force in eTMF management for clinical trials.

Prior to the creation of the TMF Reference Model, there was no universal methodology for the organization of trial data in an eTMF. In 2009 Phlexglobal joined other industry TMF experts to create the TMF Reference Model which has primarily focused on organizing the artifacts of a clinical trial.

While the TMF-RM has aided in the organization of artifact, the transfer of TMF to trial sponsors or contract research organizations has often required a significant amount of mapping and manipulation. Phlexglobal has extensive experience migrating millions of TMF documents across countless systems. The Exchange Mechanism Standard facilitates the transfer of this data, and by adopting it Phlexglobal will bring order to the interchange of trial master file content, metadata, audit trail and electronic signature information between organizations and systems. Phlexglobal is an active contributor in the eTMF-EMS development, providing valuable insight to the collaborative effort.

“Standardization is crucial to TMF success,” said Karen Roy, Chef Strategy Officer at Phlexglobal and the Chair of the TMF RM steering committee. “Phlexglobal has a steadfast resolution to lead the way in eTMF standards so we can ensure our customers’ records are always compliant and inspection-ready. Combined with Phlexglobal’s industry-leading expertise in TMF management, the eTMF-EMS will enable us to migrate TMF data in a variety of situations with a minimal amount of manual work.”

Ms. Roy will join other members of the TMF-RM steering committee in presenting the new standard at the DIA Annual Meeting on Tuesday, June 26 at 5:30 pm at the Westin Boston Waterfront Hotel. All attendees are encouraged to join this free event to learn how the eTMF-EMS will revolutionize data exchange. More information can be found at https://tmfrefmodel.com/category/news/. Registration is not required but would be useful for an indication of attendance.

About The TMF Reference Model eTMF-EMS

The TMF reference model eTMF-EMS subgroup was founded in 2015 and has been developing a standard which is aligned with the main TMF Reference Model to facilitate interchange of TMF content between organizations and systems.

More information can be found here: https://tmfrefmodel.com/ems/

About Phlexglobal

Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market. We offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.

Contact information

Phlexglobal Ltd
Rebecca Fuller, Marketing Executive
Tel: +44(0)1494 720420

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