Version 3.0 of the Trial Master File Reference Model Available
Version 3.0 of the TMF Reference Model incorporates feedback from its extensive industry use to enhance content clarity.
Version 3.0 of the TMF Reference Model incorporates feedback from its extensive industry use to enhance content clarity. Highlights of V 3.0 include updated artifacts, zones, definitions, sub-artifact examples, and a TMF Reference Model User Guide. An improved presentation of the model will be available soon after the release to facilitate easier navigation. In addition, by Q4 2015, an XML-based mechanism for simplifying the inter-change of electronic TMF content between organizations will be added.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
