Version 3.0 of the Trial Master File Reference Model is here!
Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, Version 3.0 of the TMF Reference Model (released at the DIA Annual Meeting in Washington, DC on June 16th) incorporates feedback from its extensive industry use to enhance content clarity. Highlights of V 3.0:
- Updated artifacts – Additions, deletions, consolidations
- Updated zones – Zones have been reassessed for logical artifact inclusion – E.g. local labs
- Updated definitions – That more accurately describe the TMF RM components
- Sub-artifact examples – assists with mapping to and understanding purpose of artifacts
- TMF Reference Model User Guide – Provides step-by-step process for mapping your organization’s TMF to the TMF RM
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.
Join us at the DIA Annual Meeting
TMF RM members will be networking at DIA and will be holding a Meet & Eat in the Community Networking Area on Tuesday the 16th at 12:30pm. This area is adjacent to the Member Lounge and both are near the Lunch Voucher Pick-up at the entrance to Hall B in the Exhibit Hall.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
POETYK PsA-2 Trial Shows Efficacy of Sotyktu as an Oral Therapy for Psoriatic Arthritis
March 11th 2025Sotyktu (deucravacitinib) demonstrated significant efficacy in improving psoriatic arthritis symptoms compared to placebo in the Phase III POETYK PsA-2 trial, with a well-tolerated safety profile.
