CDISC US was a great opportunity to meet customers, colleagues, and fellow industry experts face to face – both for the first time and re-connecting after a year or more away. There was a fantastic TMF turnout and a definite buzz in the room from the start of day one.

For the first time at a conference, I wasn’t on the agenda to present, which meant escaping the usual anxiety that comes with knowing I’ll be stepping onto a stage. I have to admit, a small part of me felt a little envious of those who were – something I never thought I’d say!

The agenda offered a strong mix of sessions and, with both TMF tracks conveniently located in adjacent rooms, it was easy to move between them and follow the conversations that felt most relevant in the moment. There were many familiar faces and familiar, expected themes, but there were also quieter signals of where the industry may be heading next.

Despite two energizing and packed days, I left with a more reflective and melancholy feeling than I expected – and it wasn’t just the jet lag. On my flight home, I found myself seated next to a young, enthusiastic data scientist working in translational research. As often happens, we got talking about the industry and my trip to attend a conference, among other things. Then he asked a simple question: “Any hot takes?”

I couldn’t answer him immediately.

But somewhere over the course of a nine-hour flight, with too little sleep and plenty of time to think, the answer became clear:

The next generation of TMF is arriving faster than many of us expected.

The first generation was paper. It was a comparatively simple era, defined by reactive TMF management, manual processes, and limited metrics or reportable data. We lived firmly in a document-first world – where if it wasn’t documented, it probably did happen, and someone had simply forgotten to file it.

The second generation was shaped by the TMF Reference Model and the rise of the electronic Trial Master File. Suddenly, the industry was embracing proactive TMF management, placeholders, expected documents, metadata, filing structures, and of course, metrics. TMF management became more collaborative. Accountability became clearer. The profile and importance of the TMF were elevated.

My own TMF career played out across both generations, and I’ve seen first-hand how the role, expectations, and skill set of TMF professionals have evolved along the way. In the first generation, the essentials were being highly organized, detail-oriented, and comfortable with basic Excel skills – not forgetting being able to assemble an archive box in less than 30 seconds. By the second generation, the role had expanded to include data literacy, communication, influence, persuasion, and the ability to adapt quickly to new systems.

And now we are entering the next generation.

If the first generation was paper, and the second was digitization and structure, then the third generation is about intelligence, judgment, and adaptation. It is being shaped by several major shifts happening at once, and that is exactly why it feels so significant.

One of the clearest catalysts is ICH E6(R3). More than just another regulatory update, it feels like the trigger for many of the new approaches now taking hold across the industry. Its emphasis on proportionality, quality by design, and risk-based thinking is pushing organisations to rethink what good TMF management actually looks like. We are moving toward risk-based TMF management, where the focus is not simply on the presence of every possible document, but on whether the TMF contains the right evidence to demonstrate trial conduct, oversight, and decision-making.

That is a fundamental shift. For a long time, the weight of documentation has too often been treated as a proxy for quality. The next generation challenges that assumption. It asks us to think less about volume and more about value – less about whether we have everything, and more about whether we have the evidence that matters.

This made me reflect on something I spoke about back at HSRAA in 2023 – maintaining simplicity while embracing technology. At the time, the message was about stripping away unnecessary complexity and reconnecting with the core purpose of the TMF. Not over-engineering a process so it becomes unmanageable. That message now feels even more relevant. This next generation is not about building a bigger, more complex TMF. It is about building a smarter, more efficient one.

At the same time, artificial intelligence is moving rapidly from concept to practical application. This is where this next generation starts to feel very real. Many of the process-driven tasks that have traditionally sat within TMF roles – classification, quality checks, metadata review, completeness tracking, and aspects of reconciliation – are exactly the kinds of tasks AI is increasingly capable of supporting, accelerating, or replacing.

This brought me back to another previous presentation, The Big TMF Battle – AI Versus the Geek, from CDISC EU 2025. At the time, the title was intentionally provocative, but it captured a question many of us were already starting to ask: what happens when technology starts to challenge the tasks that have traditionally defined our roles? Looking at where we are now, both of those presentations have, in their own way, become reality – but particularly the second one.

The battle is no longer theoretical, it is here and it is happening.

The human does not disappear, but the role does change. The likely future is one where AI takes on more repetitive, rules-based activity, while TMF professionals provide oversight, verification, context, exception management, and judgment. We may spend less time doing the task ourselves and more time assuring that it has been done correctly, consistently, and in a way that stands up to scrutiny.

That also raises an uncomfortable but important question: will AI prove to be both more accurate and cheaper in the long run? If the answer is yes, the shift will accelerate. If the answer is more nuanced, then organisations will need to be honest about where automation truly adds value and where human expertise remains essential.

The third force shaping this generation is the CDISC TMF Standard Model V1. Standardization has always been a worthy goal, but never an easy one. A more aligned model has the potential to improve consistency, support better interoperability, and reduce some of the long-standing inefficiencies created by varying interpretations of filing structures and metadata.

But as with any major step forward, there are practical questions. When will organisations adopt it? How quickly will systems and processes be ready to support it? And will the lack of full detail at this stage lead some companies to hold off until V1.1 or later before making the transition? The direction feels right, but adoption may not be immediate or uniform, and as an organisation we are preparing ourselves to advise and support on all viable directions.

So, what does all of this mean for our roles?

It means the human in TMF management will increasingly reside in the areas that technology cannot own alone: critical thinking, interpretation, risk assessment, oversight, and influence. The value of the TMF professional will be less about processing documents and more about understanding whether the TMF tells the right story, contains the right evidence, and reflects the true conduct of the trial.

That almost certainly means another evolution in skill set, and this is something we are preparing for as an organisation.

Organisation and attention to detail will still matter, but they will no longer be enough on their own. The next generation will demand stronger risk-based thinking, digital fluency, data interpretation, confidence working alongside AI, and the ability to challenge whether a process is creating meaningful evidence or simply more noise. It will also require stronger communication and influence – because part of the role will be helping organisations let go of old habits and become comfortable with a more intelligent, evidence-led approach.

That, to me, is the hot take.

The next generation is not just about new technology. It is not just about new standards. And it is not just about new regulations. It is about a deeper shift in what TMF management is for, how it creates value, and what kind of professionals it will need next.

The next generation is already here.

The only real question is are you ready to evolve with it?

Jacki Petty, Associate Director, Study Resourcing & Consulting

Jacki brings 20 years of TMF experience to Phlexglobal, now heading up the Study Resourcing & Consulting group, leading global teams and delivering practical, user-friendly TMF solutions. With a people-centric approach, Jacki is known for driving project health and customer satisfaction through data-led insights and continuous improvement.