The Quality Issue June 2026
AI and Intelligent RBQM: From Pilot to Operating Model
The industry has been talking about AI in clinical trials for years. In 2026, the conversation has shifted. AI is no longer a pilot project or a proof of concept. It is becoming the default operating model for sponsors and CROs that are serious about quality, speed, and oversight at scale.
Clinical trials have always generated more data than teams can meaningfully review. Sites multiply, protocols grow more complex, and the volume of signals requiring human attention has long outpaced the capacity to act on them. For years, the industry knew what good looked like: proactive, continuous, risk-proportionate oversight. The tools to deliver it consistently at scale can be challenging.
AI has changed that. Intelligent RBQM systems now learn continuously from historical and live trial data, identifying risk patterns before they escalate, surfacing the signals that matter, and enabling teams to shift from reactive correction to proactive prevention. The result is faster intervention, smarter resource allocation, and quality management that keeps pace with the trial rather than chasing it.
Timing matters. ICH E6(R3), now adopted by the FDA , European Medicines Agency Medicines and Healthcare products Regulatory Agency, and Health Canada | Santé Canada , has made intelligent, risk-proportionate oversight a regulatory expectation.
Risk is referenced 87 times in the new guidelines. Centralized monitoring, adaptive oversight, and continuous quality assessment are no longer best practice aspirations. They are what regulators expect to see in an inspection.
This is where AI earns its place. The same capabilities that make AI-driven RBQM operationally powerful: continuous learning, real-time signal detection, traceable outputs – are precisely what E6(R3) demands. Organizations that have invested in intelligent RBQM are not just running better trials. They are building the most defensible, inspection-ready programmes in the industry.
The question for sponsors and CROs in 2026 is no longer whether to adopt intelligent RBQM. It is how quickly they can move from study-level implementation to enterprise-wide, continuous oversight, because that is where regulators and the best-performing programmes are already heading.
At TRI, this is exactly where we work every day. If you want to talk through what intelligent RBQM looks like in practice for your programme, we are ready.
Are You Ready for Your Next GCP Inspection?
A 100% training completion rate can still leave your team unprepared. Here is why.
Completion and competence are not the same thing. Training records confirm that people attended. They do not confirm that people can apply GCP when it counts. In an inspection, that distinction matters. Our latest blog cuts through the noise with five straight questions that reveal whether your team is genuinely ready or just well-documented. Each question includes a score-yourself section so you can benchmark where you stand today and identify exactly where to focus.
If your next inspection is on the horizon, this is worth five minutes of your time.
Upcoming webinars – Free to attend – Sponsors and CROs Only
RBQM Risk-Based Everything – Except the CRA | 9th July 2026 | 3:00 PM BST
With Tammy Finnigan , COO, TRI and Imogen Bates , Senior RBQM Operations Consultant, TRI.
RBQM promised to transform clinical trial oversight. And it has. Almost. The CRA is still on site, still working through SDV backlogs, still measured in ways that reward activity over outcomes. Something got left behind. Tammy and Imogen are ready to call it out, and fix it. In this session, they make the case that RBQM’s unfinished business is not a technology problem. It is an organisational one. And the solution is closer than you think.
In this session, you will explore:
• Why the CRA role has remained largely unchanged despite the shift to risk-based models
• What a CRA role genuinely built around risk looks like in practice
• How auditor-style site visits can refocus attention on critical processes and data
• How monitoring intensity can be driven by real site signals rather than fixed schedules
• The shift from routine checker to site intelligence specialist, and how to get there
Coming Soon – Watch This Space
Duncan Hall ‘s presentation at COGCRO UK stopped the room. The interest it generated was significant enough that we are bringing the full session to a wider audience as a dedicated webinar. Duncan will pick up exactly where he left off in London. If you were there, you already know what’s coming. If you weren’t, this is your chance.
That is it from us for June. We hope you found something useful in this issue.
This newsletter is shaped by what matters to you. If there is a topic you would like us to cover, a webinar idea you think the community would benefit from, or something you feel deserves more attention in the industry, we would love to hear it. Get in touch and let us know.
Until next time, thanks for reading.
The TRI Team