CDISC TMF Standard Model V1: Prepare to Transition With Confidence

Minimize risk, protect inspection readiness, and position your TMF for what's next

V1 is expected to bring some of the most significant TMF structure changes in years. Early preparation means your team is ready to move confidently once the standard is finalized.

Request a consultation

WHY PREPARE NOW?

The Cost of Waiting Outweighs the Cost of Planning

Teams that wait until V1 is finalized will have less time to align processes, systems, and training once adoption is expected. Starting now means:

  • Reduced Transition Risk — catch structural and process gaps before they become compliance issues

  • Protected Inspection Readiness — keep your TMF audit-ready throughout the shift, not just after it

  • Studies that Keep Moving — a phased, study-by-study strategy means ongoing work doesn't stall

  • Long-term TMF Health — teams and systems ready to operate confidently under the new standard

HOW WE CAN HELP YOU GET READY

Expert Support Across Every Part of the Transition

Phlexglobal helps sponsors and CROs prepare for V1 now, so your team can move quickly and confidently once the standard is finalized. This is expert-led support, not a self-serve checklist.

  • Structure Mapping & Gap Analysis — Understand how your current model aligns to V1 and identify areas requiring change

  • Study Transition Strategy — Determine which studies should transition and when

  • Process & SOP Impact Review — Identify and manage the broader impact on your TMF

  • Change Management & Communications — Prepare stakeholders and simplify the transition through a phased approach across your organization

  • Study Team Readiness Training — Equip teams to work effectively in the new model and minimize disruption

A Guided Path From Assessment to Adoption

Once the standard is finalized, here's the path we'll walk with you:

1. Assess

Understand Current-state Impact: Evaluate your organization’s preparedness for adopting the new standard.

2. Plan

Understand Current-state Impact: Evaluate your organization’s preparedness for adopting the new standard.

3. Prepare

Understand Current-state Impact: Evaluate your organization’s preparedness for adopting the new standard.

4. Pilot

Understand Current-state Impact: Evaluate your organization’s preparedness for adopting the new standard.

5. Adopt

Understand Current-state Impact: Evaluate your organization’s preparedness for adopting the new standard.

Phlexglobal Website Backgrounds_Dots v1

Ready to prepare for your V1 transition?

Let's build a readiness strategy now, so you're set to move the moment V1 is finalized.

Request a consultation

TMF Expertise In Action

Connect with Phlexglobal experts and stay up-to-date on the latest pharmaceutical, biotech and medical device industry trends.

TMF Standard Model V1 Transition: Preparing for Change

When my Trial Master File (TMF) career began, the TMF Reference Model did not exist. Every customer had a different way of organising the contents of their TMF, and it was rarely interpreted

A Day in the Life: TMF Team – What Type of TMF Resource Do You Actually Need?

Building the Right TMF Team for Inspection Readiness, Scalability and Growth As clinical trials become more complex, many Sponsors and CROs find themselves asking the same question: Do we need more

A Day in the Life: TMF Program Lead - The Hidden Cost of Managing Studies One at a Time

Why portfolio-level TMF oversight is becoming a necessity, not a luxury. The Problem With Thinking Study-by-Study Clinical trials do not happen in isolation. Sponsors and CROs are running multiple