--- title: TMF Week 2026 - Call for Speakers description: Share your TMF expertise on R3, digital transformation, and AI governance at TMF Week 2026. Submit your proposal by March 27th, 2026. image: https://info.montrium.com/hubfs/Call%20for%20Speakers%20%281%29.jpg --- [![Montrium](https://info.montrium.com/hs-fs/hubfs/montrium_logo_2023_gradient.png?width=192&height=40&name=montrium_logo_2023_gradient.png "Montrium")](https://info.montrium.com/) - [About us](https://www.montrium.com/) # TMF Week 2024 On-Demand # ![TMFWeek2026_Logo](https://info.montrium.com/hubfs/TMFWeek2026_Logo.svg) ### CALL FOR SPEAKERS VIRTUAL CONFERENCE DATES: June 8-10, 2026 9:00 AM - 1:00 PM ET DEADLINE TO SUBMIT: March 27th [Become a speaker](https://info.montrium.com/tmf-week-2026-call-for-speakers#register)   ## Bring your expertise. Help lead the future of TMF management ![Arrow_section](https://info.montrium.com/hubfs/Arrow_section.svg) This year, one question drives every session: what do TMF teams need to know ***right now**?* We're assembling leaders, practitioners, and innovators with hard-won experience to deliver actionable sessions around three forces reshaping TMF management: R3 compliance, digital transformation and standardization, and AI governance. If you've navigated these topics firsthand, we want you on stage. ## Meet the keynote & host ![Arrow_section](https://info.montrium.com/hubfs/Arrow_section.svg) ![Paul Carter](https://info.montrium.com/hs-fs/hubfs/Paul%20Carter-3.jpg?width=400&height=400&name=Paul%20Carter-3.jpg "Paul Carter") ### Paul Carter Paul co-founded Montrium in 2005 and brings over 20 years of senior leadership experience in clinical trial technology and regulated systems. He currently serves as Chair of the CDISC TMF Reference Model Steering Committee. President & CEO @Montrium ## What’s in it for you Speak at **TMF Week 2026** to demonstrate your expertise in the most critical areas of TMF management today. ![PeopleRounded](https://info.montrium.com/hubfs/PeopleRounded.svg) ### **Connections that count**  Engage with TMF professionals, industry leaders, and technology innovators across the life sciences industry. ![RecordVoiceOverRounded](https://info.montrium.com/hubfs/RecordVoiceOverRounded.svg) ### **Influence and impact** Help your peers move forward on R3, data standardization, and AI adoption. Share frameworks grounded in real experience.  ![FlareRounded](https://info.montrium.com/hubfs/FlareRounded.svg) ### **Visibility and recognition** Position yourself as a subject matter expert on topics that define the future of TMF management.  ## TMF Week speaker certificate ![Recognition_Certificate (1)](https://info.montrium.com/hs-fs/hubfs/Recognition_Certificate%20(1).png?width=700&height=469&name=Recognition_Certificate%20(1).png "Recognition_Certificate (1)") ### Every speaker receives an official and exclusive TMF Week 2026 Speaker Certificate. Share it on your LinkedIn profile to highlight your expertise to your network and beyond!! -   [Become a speaker](https://info.montrium.com/tmf-week-2026-call-for-speakers#register) ## Don't take our word for it. ###  Hear what past attendees had to say about TMF Week: ![Quote_attendees](https://info.montrium.com/hs-fs/hubfs/Quote_attendees.png?width=600&height=441&name=Quote_attendees.png "Quote_attendees")   ## Explore the themes ![Arrow_section](https://info.montrium.com/hubfs/Arrow_section.svg) Below you will find the three themes for **TMF Week 2026**. Select the theme(s) that best fits your expertise and tell us what you would like to contribute. - **Theme #1 -** **R3, Risk, and the Road Ahead for TMF Management** ICH E6(R3) is reshaping TMF oversight and sponsor accountability. Risk-based approaches are now expected, and execution is under scrutiny. Sponsors, CROs, and inspectors are redefining what effective oversight looks like. **This theme** **will help attendees** understand how to structure oversight models, apply risk-proportionate approaches, and prepare for inspections under R3. Topics to consider (but not limited to): • The new rules of TMF oversight under R3 • Real-world applications of risk-proportionate approaches • Risk-based quality management and its intersection with TMF oversight • The evolving sponsor oversight model in a risk-based, remote world • Lessons from recent inspections in a post-R3 environment   **Theme #2 - Keeping Pace with Digital Transformation and Standardization** Trials are becoming more complex and decentralized. Standardization, system alignment, and data governance are now inspection priorities. Inconsistent records, weak metadata, and unclear data ownership are common findings. **This theme will help attendees** define data and records standards, align IT, clinical operations, and quality, and prepare for the shift to the TMF Standard. Topics to consider (but not limited to): • What “digital TMF” means in practice versus perception • The shift to structured data models, including ICH M11 and Digital Data Flow • The standardization of records data • Data integrity challenges in decentralized trials • Cross-functional alignment across IT, clinical ops, and quality • The shift from the TMF Reference Model to the TMF Standard • The role of metadata and taxonomy in driving standardization   **Theme #3 -** **The AI Era and the Governance Imperative** AI adoption is accelerating faster than regulatory guidance. Governance gaps create operational and compliance risk. Organizations are testing AI, but oversight models are still forming. **This theme will help attendees** understand how to govern AI use in TMF operations, validate tools, and build oversight frameworks. Panelists may share their AI experiments, governance frameworks, what has been working, and what has not. Topics to consider (but not limited to): • AI applications in TMF management (risks, challenges, successes) • Upskilling the TMF professional for AI-augmented future (new skills and mindsets) • Validation of AI tools in regulated environments • Human-in-the-loop models for AI oversight • Scaling AI responsibility in TMF operations • Governance frameworks and AI guardrails in practice • Navigating today's AI guidances and regulations (EMA, FDA) • Understanding how inspectors assess current AI use in TMF      ---   ## See what attendees are saying about TMF Week ![Arrow_section](https://info.montrium.com/hubfs/Arrow_section.svg) *"Too Much Fun!"
* — Danea Martinez Fagundo, Team Coordinator CTA *"I really enjoyed hearing different perspectives on the eTMF landscape. The meetings were presented well."
* — Tara Morris, Consultant - TMF "*It was nice learning and very insightful event...Let's keep the momentum going — because when it comes to TMF, every document tells a story, and every detail matters. Stay Organised, Stay Audit Ready and most importantly Stay Curious!!"* — Rita Goyal Jain, Manager Quality Assurance & Training   [Become a speaker](https://info.montrium.com/tmf-week-2026-call-for-speakers#register) **How to submit**   We accept proposals for both individual sessions and panel discussions through a single submission form. No vendor pitches. You can either submit an abstract based on your selected theme(s) or explain why you would be a good fit to speak on a panel. The review committee evaluates submissions on specificity, practical value, and relevance to the year's themes. Concrete, real-world experience strengthens a proposal. Proposals with clear examples, lessons learned, and practical takeaways are prioritized. Submit your abstract by March 27, 2026 We review every submission carefully. You'll hear from us with an update in mid-April.    ![Divider](https://info.montrium.com/hs-fs/hubfs/Divider.webp?width=800&height=150&name=Divider.webp) --- --- ## Get our best content delivered straight to your inbox ![Arrow_outline_gr](https://info.montrium.com/hs-fs/hubfs/Arrow_outline_gr.png?width=50&height=50&name=Arrow_outline_gr.png) ![Arrow background 1](https://info.montrium.com/hs-fs/hubfs/Arrow%20background%201.webp?width=70&height=70&name=Arrow%20background%201.webp) ![Arrow background 3](https://info.montrium.com/hs-fs/hubfs/Arrow%20background%203.webp?width=100&height=100&name=Arrow%20background%203.webp) ![Arrow background 4](https://info.montrium.com/hs-fs/hubfs/Arrow%20background%204.webp?width=151&height=151&name=Arrow%20background%204.webp) ### Want to speak at TMF Week 2026? ##### Submit your entry today! 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