AMERSHAM, UK, June 21, 2018 - 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 PhlexTMF, 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.