Flex Databases is fully ready for the transition to the new TMF Standard Model (TMF SM)!
October 31, 2025
📑 The TMF Reference Model, widely used across the industry for more than a decade, is being reintroduced under a new name: TMF Standard Model (TMF SM).
🚀 Instead of releasing Version 4 of the TMF Reference Model, the upcoming update will debut as TMF Standard Model Version 1 (v1). This rebranding represents more than just a change in numbering, it reflects a transformation toward a scalable, adaptable, and digitally enabled framework that better supports the future of clinical research.
✅According to CDISC, the TMF Standard Model v1 will include:
✅Expanded 2,000+ Record Types for more precise and consistent documentation
✅Updated guiding principles aligned with modern regulatory requirements
✅A stronger foundation for interoperability with sponsors, CROs, and technology providers
This shift demonstrates the industry’s commitment to strengthening TMF structure, data quality, and long-term digital usage. The new model aims to improve how organizations plan, manage, track, and archive TMF content across studies.
📌 CDISC will present full details during the
TMF Standard Model v1 Project Webinar
6 November 2025 | 11:00am – 12:00pm EST
For more information, visit: CDISC TMF Standard Model v1 Project Webinar
👉 https://lnkd.in/eWDK-PJz
At Flex Databases, we see this evolution as a natural step toward smarter, more future-proof TMF management. With AI-driven automation, intuitive workflows, and compliance-by-design capabilities, we are ready to support our clients in the transition to the TMF Standard Model era.
