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.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
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.
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.
