The Quality Issue August 2026
End of Summer, Start of Smarter Monitoring
The Summer Wrap-Up
The August bank holiday is nearly here, and for those of us in the UK, that long weekend feels like the official closing bell on summer. Before the pace picks back up for autumn, we wanted to pause and ask: how has your summer been?
Whether you spent it catching up on protocol reviews, actually taking that vacation you promised yourself in January, or some combination of the two, we hope it gave you a proper break. September brings a busy conference season, so consider this newsletter your last easy read before things speed up again.
AI in RBQM: Where Do You Stand?
Conference season is about to fire back up, and if last year is anything to go by, one topic will dominate every agenda: AI in RBQM. From protocol design through to signal detection, AI is being pitched as the natural next step for risk-based quality management, promising faster, more consistent oversight without adding headcount.
Adoption tells a more mixed story, though. Some sponsors and CROs are moving quickly, building AI into risk assessments and central monitoring outputs. Others are holding back, weighing up validation burden, data provenance questions, and how much trust to place in a model’s output when patient safety is on the line.
ICH E6(R3) does not mandate a particular technology, but it does set a clear bar: proportionate, risk-based oversight with a documented, traceable rationale behind every decision. Whatever role AI plays in your RBQM approach, it needs to work inside that framework, not around it.
So, we want to know: are you embracing AI in RBQM, or still watching from the sidelines? Reply and let us know where you stand, we will share what the community says in next month’s issue.
What Makes a Good Monitoring System?
Choosing a centralized monitoring system is not just a software decision. It is a decision about how your team spots risk, protects patients, and stays inspection ready for the life of a study.
Our latest blog sets out the questions worth putting to any vendor before you commit, from how a platform separates meaningful signals from noise, through to whether it can demonstrate data lineage and scale across different study phases and populations. It is a practical checklist for anyone building or refreshing their evaluation criteria.
Whether you are running a formal RFP or just want a sense check on your current setup, these are the questions worth asking.
Read the full blog to get all the questions.
How Do You Close the CRA Gap?
Back at the start of summer, our Chief Operating Officer Tammy Finnigan and Senior RBQM Operations Consultant Imogen Bates hosted a live session on one of the most overlooked gaps in RBQM: the CRA role itself.
The premise was simple. Risk-based quality management has transformed almost every part of clinical trial oversight, except the CRA, who in many organizations is still working through SDV backlogs and still measured on activity completion rather than outcomes. Tammy and Imogen made the case that this is not a technology problem, it is an organizational one, and it is closeable. The fix starts with redefining the CRA as a site intelligence specialist rather than a data checker, splitting activity into scheduled Site Quality Visits and signal-driven Triggered Activities, and rewriting monitoring plans, SOPs, and training to match.
We covered the diagnosis. Part Two goes further, with the practical steps for putting this new model into practice. Dates will be confirmed next week, but if you comment “yes please” to this newsletter, we will add you straight to the registration list so you do not have to keep an eye out for the announcement.
Missed Part 1? Catch the full recording here.
That is a wrap for this month’s Quality Issue. Enjoy the long weekend, and we will see you back here in September.
The TRI Team