The Quality Issue September 2026
Summer is behind us, conference season begins…
Can Your AI Stand Up to Inspection?
AI in RBQM has moved past the pilot stage. Purpose-built tools now support risk-based quality monitoring and centralized data review, flagging the sites and participants that need attention before problems compound. For sponsors and CROs, oversight effort goes where the risk is, not where the schedule says.
The conversation has shifted, though. Sponsors are no longer asking whether to use AI. They’re asking where it genuinely improves data quality and decision-making without introducing risk they can’t defend.
Regulators are asking the same question. In January, the FDA and EMA published their joint Guiding Principles of Good AI Practice in Drug Development, which set shared expectations for how AI should be validated, monitored, and governed across the medicines lifecycle, including clinical trials.
ICH E6(R3) now puts proportionate, risk-based oversight at the center of GCP. Annex 2 was adopted in June and takes effect in the EU on 15th January 2027. It completes the framework and adds clearer expectations on sponsor oversight and on whether data are fit for purpose.
The takeaway for quality leaders: if AI is shaping your monitoring decisions, you need to be able to show how. Human oversight and a traceable rationale for every signal acted on will separate the teams that scale AI with confidence from those that stall at inspection.
Can you show an inspector how a risk drove your monitoring plan? Our latest blog sets out what to check in your RBQM platform: 7 Things to Check in RBQM Software in 2026
Have You Spotted Us Yet?
Event season is in full swing, and September didn’t hold back. We joined the CRO community in Amsterdam for the PBC Group – Organisers of the COG Series, COG CRO Summit Europe, then headed to Raleigh, North Carolina, for the Society for Clinical Data Management (SCDM) Annual Conference. Thank you to everyone who stopped by for a conversation.
October brings two more:
• SCOPE Europe, Barcelona, 13th and 14th October. SCOPE Europe is now in its ninth year, and we’re proud to be part of the RBQM track again, with Duncan Hall Hall, our CEO, presenting. Find us at booth #36.
• Outsourcing in Clinical Trials Nordics, Copenhagen, 20th and 21st October. You’ll be able to catch up with Tim Collard and Jelena Kozyrickaja at booth #47.
And this season, we’ve got something to shout about.
Some of you may have already caught a hint in Amsterdam or Raleigh. We’re not saying much yet. It has been a long time in the making, and Barcelona is where it steps into the spotlight.
If you see us this October, keep your eyes peeled and ask us what we’ve been working on. If not, don’t worry. We’ll tell all in next month’s issue.
That’s all for September. We hope to see you in Barcelona, in Copenhagen, or online.
Until next month,
The TRI Team