The Quality Issue July 2026
Why Subject Monitoring Is the Next Compliance Frontier
As the summer months settle in, many of us are taking a step back to relax, reconnect with family, and recharge before the second half of the year picks up pace. We hope you find some time to do the same. In the meantime, we’ve kept a close eye on the latest industry data so you can stay informed without it costing you your holiday reading list.
Industry Spotlight: What ACRO’s Latest Survey Tells Us About Subject Monitoring
The Association of Clinical Research Organizations has released its seventh consecutive RBQM landscape survey, and the direction of travel is clear. In 2025, 90 percent of clinical trials included at least one risk-based monitoring or RBQM component, up from just 53 percent in 2019. Reliance on fully traditional monitoring methods has fallen from nearly half of all studies in 2019 to just 10 percent today.
But adoption is not the same as maturity.
“Mid-size sponsors had higher adoption rates across the board compared to large or small sponsors… Phase III studies were more likely to utilize QTLs, KRIs, and centralized monitoring.” – ACRO RBQM Landscape Survey, 2025.
Centralized monitoring and key risk indicator use, while both up again in 2025 (11 percent and 7 percent respectively), still sit at around half of new study starts. And despite the broader shift toward risk-based thinking, full source data review and verification remains common practice on most studies, often used as a safety net rather than a deliberate strategy.
The gap the data points to is not a lack of appetite for risk-based approaches. It is a lack of tooling built to make centralized, real-time subject monitoring straightforward enough to fully replace the spreadsheet-and-manual-review habits that still dominate.
Read the full ACRO report here.
That gap is precisely what our upcoming webinar addresses.
Beyond Spreadsheets: A Smarter Approach to Subject Monitoring
Join Greig Duncan and Ian Jonas on Thursday 20th August 2026 at 3:00 PM BST for a 30-minute session built for teams who want sharper, real-time control over safety-critical patient-level data.
We will look at why manual subject monitoring creates blind spots, walk through oncology and rare disease case studies where automated monitoring has replaced static spreadsheets, and unpack exactly why traditional approaches fall short under ICH E6(R3), plus what that means for your compliance strategy.
Thanks for reading this month’s Quality Issue. We hope you enjoy a well-earned break this summer, and we’ll see you back here in August with more insight from the world of RBQM.
The TRI Team