Phlexglobal Partners with PRA Health Sciences to Create the Global TMF Center of Excellence

Phlexglobal has announced the successful creation and implementation of the Global TMF Center of Excellence with partner PRA Health Sciences.

Given the increasingly critical role played by the Trial Master File for supporting Good Clinical Practice (GCP), audit and inspection preparedness, and streamlined submissions, PRA conducted a comprehensive, multi-round review of TMF providers and chose Phlexglobal after a competitive bidding process. Building and implementation of PRA’s fit-for-purpose TMF Center of Excellence solution commenced shortly after the project award was given in early 2019.

With insights from the Global TMF Center of Excellence, PRA assists pharmaceutical and biotech sponsors in compliance and reducing risk by ensuring ongoing inspection-readiness with expert management of the quality, completeness, and timeliness of the Trial Master File. PhlexTMF technology supports this by providing effective sponsor oversight, streamlining collaboration and communication, and easily managing millions of documents across hundreds of studies.