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.
Read the full release, here.
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
May 2nd 2025Interim results from the Phase III ESSENCE trial published in The New England Journal of Medicine show once-weekly semaglutide improved liver histology, metabolic markers, and weight loss in patients with biopsy-confirmed metabolic dysfunction–associated steatohepatitis and stage 2 or 3 fibrosis.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
