Only 57% of clinical trial organizations have adopted the core components of risk-based quality management, according to a 2023 Tufts Center for the Study of Drug Development study, and a new on-demand webinar from eClinical Solutions argues that disconnected technology is a primary reason the number stays that low. The session, “From Silos to Synergy: How Tech Can Make or Break RBQM,” focuses on a specific structural failure: data management, medical monitoring, and central monitoring teams working from separate review plans with inconsistent definitions of what counts as critical data.
That inconsistency is not a workflow inconvenience. When teams disagree on which data signals require action, central monitoring produces flags that medical monitors never see or act on, and risk oversight collapses in the gap between departments. The FDA’s 2023 updated guidance on risk-based monitoring expects sponsors to demonstrate integrated, documented oversight. Fragmented systems make that documentation nearly impossible to produce cleanly, which converts an operational problem into a regulatory exposure.
A 2019 survey found that 99% of clinical operations respondents identified a need to unify their trial systems, with better visibility the top driver at 70%. That near-universal recognition did not produce near-universal integration. The webinar’s framing suggests the obstacle is less awareness and more architecture: organizations have layered point solutions onto existing processes without connecting the outputs, so each function generates its own data view and risk assessments never converge into a single picture of study health.
The practical test for any sponsor watching this is whether their central monitoring alerts feed directly into the same environment where medical monitors document their review decisions. If those two records live in separate systems and require manual reconciliation, the RBQM program is producing the appearance of oversight rather than the substance of it. That is the gap the webinar addresses, and it is also the gap Tufts CSDD’s data suggests nearly half the industry has not yet closed.
Source link: https://www.eclinicalsol.com/event/from-silos-to-synergy-how-tech-can-make-or-break-rbqm-on-demand/
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
