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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.