ACRO’s latest RBQM Summary Report makes one thing clear: the clinical research industry has moved past questioning the value of RBQM and moving the conversation to how well organizations are putting it into practice. In 2025, nearly 90% of clinical trials included at least one RBM or RBQM component, which shows strong momentum, but also highlights that adoption alone does not equal maturity.
Most studies still rely on broad, 100% SDR/SDV approaches, and only a subset use structured risk assessments, KRIs, or centralized monitoring in a way that truly drives oversight decisions. In other words, the market has embraced the RBQM label far faster than it has adopted a genuinely risk-based monitoring operating model.
RBQM maturity is held back by three persistent gaps that ACRO’s summary brings into focus:
For many smaller sponsors, centralized monitoring still feels like a major shift in both tooling and skills. Lean teams may worry about the perceived cost and complexity of new platforms or feel uncertain about how regulators will view a move away from long‑established visit schedules and SDV. Without confidence in their ability to interpret aggregated data and act on emerging signals, they often keep central review at the margins rather than making it the backbone of oversight.
Even in FSP and multi‑vendor models, oversight accountability sits with the sponsor, which often leads teams to retain 100% SDV as a defensive back‑up rather than trusting risk-based oversight and clear escalation criteria.
This matters because RBQM is not meant to sit beside traditional monitoring as an extra layer of process but should reshape how teams think about risk and respond when patterns begin to emerge. The most forward-looking takeaway from ACRO’s report is that RBQM is becoming a marker of maturity. The organizations that will stand out are the ones that can show how RBQM improves trial quality in practice, rather than referencing it as a principle alone. Closing that gap is where real competitive advantage now lies.
TRI helps clinical research teams turn RBQM strategy into practical execution.
ACRO’s report does not suggest that RBQM has arrived in its final form, however, showcases that the industry is still learning how to use it well. Despite many organizations having a long way to go, it creates an opportunity to lead, by building RBQM into the way trials are designed and managed every day.