As we dust ourselves off from 2025, we rub our bleary eyes and 2026 starts to come in to focus. Last year was the start of some of the biggest changes we have seen in over a decade, new guidelines, upcoming standards and the looming impact of AI.
You’ll notice I said “start”, that’s because it is nowhere near finished and this year is poised to be one that will make us laugh, make us cry, celebrate the small wins and prepare for the more to come.
I can’t predict the future, if I could I would be on a private island somewhere enjoying my millions from getting in early on the Pokémon trading card hustle, what I can do though is share with you my thoughts for what 2026 has ready for us, what we should look out for and what you may need to catch up on.
Here are my 6 for 2026 of things to help you get prepared for the next 12 months.
1. TMF Standard Model V1: The Preparation Year
The TMF Reference Model is undergoing its biggest transformation since inception. V3.3.1 will be the final version as we know it, with the newly named TMF Standard Model V1 planned to launch H1 2027i. This means 2026 is the year to prepare.
Here’s what makes this different: Record Types (formerly Sub-Artifacts) are now a core part of the structure. If your organisation has been filing documents at the Artifact level only, you might have some work ahead. We’re talking about approximately 2,000+ Record Typesii in the new version. Before you panic, remember that not every trial uses all 2,000, you’ll use what’s relevant to your study, it is also worth remembering we already have over 600 sub-artifacts, this expansion just reflects the reality of modern clinical trials. From an operational standpoint, 2026 is less about knowing every change coming and more about understanding impact of any change. Sponsors who can objectively assess gaps will be far better positioned to plan for success with resourcing, and inspection readiness.
The TMF Standard Model V1 isn’t just a name change, it’s a shift years in the making. We’re moving from a “model” that recommended interpretation and variation, to a “standard” that provides definitive structure and regulatory alignment.
What should you be doing in 2026:
- Make sure you keep up to date with the quarterly TMF General Meetings hosted by CDISC, this is where all the news will be shared.
- Assess your current TMF structure, are you filing at Record Type level? How different is your structure from the basic?
The vendors are aligned, the community is engaged, and the industry push is there. Question now is will you be ready?
2. ICH E6(R3): From Theory to Reality
ICH E6(R3) reached Step 4 on January 6, 2025iii. The regulatory dominoes are already falling:
- EMA (Europe): Implemented July 23, 2025iv
- FDA (US): Published guidance September 2025v
- Health Canada: Implementation effective April 1, 2026vi
- UK MHRA: New guideline effective April 28, 2026vii
- Japan PMDA: Still in assessment phaseviii
2026 is the year where E6(R3) stops being theoretical and starts being what regulators expect to see.
Health Canada’s announcement is particularly telling. They’re providing a six-month preparatory period for stakeholders to conduct training, revise SOPs, update quality management systems, and align trials with new expectations. They’re making it clear that sponsors need to identify Critical to Quality Factors with associated risks and mitigation measures. This isn’t a suggestion. Beyond SOP updates, sponsors will need to consistently demonstrate, through evidence, that oversight activities are occurring and effective across all delegated activities.
This impacts every aspect of your TMF processes and records: “Participants” instead of “subjects” across all documents, enhanced CRO oversight requirements, risk-based monitoring plans, new data governance documentation, and specific computerised systems validation.
For TMF professionals, this means updates to essential record lists, metadata requirements, quality measures, SOPs, work instructions, and training materials. With Health Canada and MHRA both implementing in Q2 2026, your TMF needs to reflect the new reality.
3. AI Goes Production in the TMF
I’ve been talking about AI for a while, RAG systems, automated test data, Vibe Coding, but 2026 is different. This is the year AI moves from “interesting pilot” to “this is how we work now.”
The AI in clinical trials market grew from $7.73 billion (2024) to $9.17 billion (2025), projected to hit $21.79 billion by 2030.ix Over 50% of major pharmaceutical companies are now “heavy AI users.”x
What’s more telling though is what I’ve seen at conferences. The tone has shifted. A year or two ago, AI presentations were met with scepticism. Now? People are sharing real implementation stories, discussing validation strategies, and problem-solving on 21 CFR Part 11 integration.
What’s actually being deployed:
As AI-supported processes move into production, regulators will increasingly expect clear governance models and evidence that these systems are monitored, controlled, and understood by the business.
- Automated document classification using ML models
- NLP for metadata extraction
- AI-powered quality checks identifying missing pages and incorrect filing
- RAG systems for internal SOPs and guidance
- Predictive analytics identifying at-risk documents
The key difference in 2026 is compliance frameworks are catching up. Companies are figuring out how to qualify these systems, maintain oversight, and explain AI-assisted processes to regulators.
If you haven’t started exploring AI tools for your TMF processes, you’re missing out on all the fun.
4. The Site System Crisis: A Problem About to Break
This isn’t a new trend, but it’s still as relevant as ever, clinical trial sites are juggling an obscene amount of systems. Research coordinators spend significant hours on redundant data entryxi. Combine that with the fact that almost a third of sites report inadequate training on all these systems, it is a recipe for disaster.
All this friction is causing more and more strain on Sponsor, CRO and Site relationships.
It is a bubbling problem that’s going to break. Sites are drowning, and when sites struggle, Essential Record quality suffers. Late submissions, incorrect metadata, poor-quality scans, often these are symptoms of overwhelmed sites in impossibly fragmented technology environments. But more important than of this, patients suffer, and that is a non-negotiable for everyone involved.
Could a ISF Reference Model help ease the pain?
In July 2025, the Investigator Site File (ISF) Reference Model was released for public review.xii Developed in alignment with TMF Reference Model V3.3.1, it provides standardised framework for site-level documents.
This matters because site documentation chaos directly impacts sponsor TMF quality. The ISF Reference Model, integrating with TMF Standard Model V1, is the industry’s attempt to bring order to site-level documentation.
What needs to happen in 2026:
- Industry push for system integration and interoperability
- ISF Reference Model adopt
