The TMF community recently came together in Denver for the CDISC US Interchange, and members of the Phlexglobal team came home with plenty to reflect on. Across sessions, hallway discussions, and time spent with sponsors, CROs, and industry peers, a few themes stood out. Organizations are preparing for the TMF Standard Model V1, looking for ways to put AI to work where it adds real value, and keeping inspection readiness at the center of it all.

Below, three members of our team share their personal takeaways from the event. They cover what the V1 transition means for organizations and why deep TMF expertise matters more than ever as new technology takes hold.

Olivier Teissedre, Chief Executive Officer

I left Denver energised after the last CDISC US meeting. It is always a pleasure and a privilege for me in my role to spend time directly with our customers and key industry stakeholders. My key takeaways from this interchange conference are:

• New V1 standards coming in April '27: This shift in the industry should not be underestimated, as it is a move from a reference model to a new standard that will be common across all of the industry players and accelerate interoperability.

• AI and Human in the loop: AI will transform our industry, as it will for many others, by accelerating the automation of some of the simplest and most repetitive tasks, providing time for sponsors to partner with vendors and elevate their strategic approach to TMF.

• Expertise as a guiding light: These changes (AI, V1) will drive new innovation which is positive for our industry to continue to position TMF as a strategic imperative in products' lifecycles. I have had the chance in my career to drive several digital changes across both Sponsors and Vendors, and every time, ensuring you have the right expertise (internally and with your partners) has been a success criteria. Bringing these changes within an organisation can sometimes feel overwhelming and uncertain.

It is our role as Vendors to ensure that we are providing that TMF expertise and outside-in perspective and act as trusted partners to our customers to go through these changes. It is also our responsibility to ensure we provide the right level of quality with new technologies with AI. Our industry will lose confidence and momentum if the speed to release these new tools is at the sacrifice of quality.

Inspection readiness remains paramount!

Seth Pearl, Head of Commercial

TMFers are ready for more than just AI. Surprise!

I'm heading home from a great CDISC + TMF event, energized about where TMF is headed. Some of that energy came from early morning walks under a pitch-black Denver sky. The air felt remarkably clean, even in the middle of the busy Tech Center, and it was a great way to start each day.

Back to TMF "readiness." Here are my highlights and observations:

1. V1 readiness is the next big step. The conversation centered on organizational readiness for the new standard. The transition will take time, and there is real opportunity for support with alignment and change management. The Standard V1 draft is expected on October 19th. Message me if you'd like to hear how we're helping organizations prepare.

2. AI is here, and the industry is ready for it. The key is applying it to value-add activities. Generalist solutions that don't address TMFers' true needs are unlikely to last. 

3. Inspection readiness remains a top priority. There is strong interest in identifying risk continuously rather than through periodic remediation exercises.

4. Metrics are old school. It's all about data intelligence. Each organization should identify its needs, measure against them, and improve based on the insights.

5. Organizations want to enhance their existing ecosystem, not replace entire platforms.

6. Expertise matters. Amid the excitement around AI, the real opportunity is intelligent automation underpinned by deep TMF knowledge.

The industry is increasingly focused on outcomes, not technology for technology's sake. Better quality, earlier risk identification, and more confident decision-making are what matter.

I'd love to continue the conversation, so please reach out!

Angie Gill, Lead Customer Success Manager

From Conversation to Transformation: Reflections from the US CDISC Conference

There’s something powerful about getting out from behind the screen and having meaningful conversations with customers face-to-face. While CDISC US Interchange is known for advancing standards and innovation, my biggest takeaway led back to the basics: sitting down with industry leaders and experts to create exciting dialogue and to listen to each person’s journey into TMF management.

Across discussions with sponsors, CROs, and industry colleagues, two topics consistently surfaced: the growing role of AI and the rollout of the Standard Model v1. Both are poised to significantly influence how organizations manage, connect, and leverage clinical information. More importantly, they're reshaping how we think about the future of TMF management.

What struck me most was that organizations are approaching this next phase from very different starting points. Some are actively exploring AI to automate manual processes, improve quality oversight, and uncover insights hidden within their TMFs. Others are focused on strengthening their foundations through greater standardization, data consistency, and interoperability. Most are trying to determine how to embrace innovation while maintaining the governance, compliance, and inspection readiness that remain critical to success.

That's why customer engagement has never been more important.

As technology evolves, our role is less about promoting solutions and more about understanding where customers are on their journey. The most valuable conversations weren't about AI capabilities or technical specifications. They were about real-world challenges: managing increasing study complexity, doing more with limited resources, preparing for future regulatory expectations, and ensuring teams are ready for change.

The organizations that will benefit most from AI and emerging standards will be those that approach transformation strategically. That starts with listening. Listening to customer priorities, understanding their level of readiness, identifying gaps, and helping create a practical path forward.
For customer engagement teams, this means focusing on three key areas:

• Listen first: Understand each organization's unique challenges, goals, and maturity level.

• Guide the journey: Help customers connect today's priorities to tomorrow's opportunities in AI-enabled TMF management.

• Build trusted partnerships: Support change management, adoption, and long-term success rather than focusing solely on technology implementation.

The future of TMF management will undoubtedly be shaped by AI and enabled by standards like the Standard Model v1. But technology alone won't drive success. Success will come from the partnerships we build, the challenges we solve together, and the conversations that help organizations confidently navigate what's next.

Technology may define what's possible, but listening to our customers is what will define what's next.

Each perspective comes from a different seat at the table, yet a common thread runs through them all. New standards and smarter technology will shape the future of TMF, but the people, partnerships, and expertise behind them will determine its success. As the industry gets ready for V1 and explores where AI fits into TMF management, Phlexglobal is committed to helping organizations move forward with clarity, without compromising quality or inspection readiness.

Ready to keep the discussion going?

Connect with our team to learn how we’re helping organizations prepare for the TMF Standard Model V1 transition.

Olivier Teissedre, Chief Executive Officer

Olivier is CEO of Phlexglobal, leading the company's growth and innovation across life sciences. He combines deep TMF expertise with a digital and AI-driven vision to redefine inspection readiness. He brings 20+ years of global executive experience in healthcare technology, including roles at Cencora, BMS, and Astellas Pharma.

Seth Pearl, Head of Commercial

Seth joined Phlexglobal in 2014, bringing nearly two decades of Life Sciences experience. As Head of Commercial, he leads Phlexglobal's go-to-market strategy, driving high performance and growth. He has built a strong reputation for developing strategic partnerships and delivering value to leading biopharmaceutical organizations.

Angie Gille, Lead Customer Success Manager

Angie Gill is a Lead Customer Success Manager with a background in life sciences, finance, and data analysis. She enjoys connecting with customers, understanding their challenges, and finding practical ways to help them succeed. With a strong interest in TMF management, continuous improvement, and emerging technologies such as AI, Angie is passionate about helping customers prepare for what’s next while keeping quality and partnership at the center.