Risk-based quality management depends on knowing what to monitor and on interpreting what the signals mean.
|Articles|August 12, 2015
OmniComm Systems' Risk-Based Monitoring Survey Results
OmniComm Systems, a global provider of clinical data management technology, announced survey results from respondents that included 16 sponsor organizations and 13 contract research organizations (CROs).
Advertisement
OmniComm Systems, a global provider of clinical data management technology, announced survey results from respondents that included 16 sponsor organizations and 13 contract research organizations (CROs). The results indicate a significant movement forward in the industry towards active risk-based monitoring (RBM) adoption with 76% of the organizations reporting that they are either already executing RBM studies (45%) or planning to initiate RBM studies during this year (31%). The survey further elucidated differences in RBM adoption between CROs and sponsors. 33% of CROs have already initiated RBM studies compared to 53% of sponsors. This result re-enforces the relative hesitance that many have observed from the CRO industry with respect to RBM. The value potential of RBM is often less immediately recognized by CROs vs. sponsors, and many instead perceive a threat to study revenues related to site monitoring.
Advertisement
Related to this article
In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.
Data capture is no longer the bottleneck, and whether the lag between a signal and a decision shrinks depends on signal design, AI governance, and vendor orchestration.
In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.
The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.
AstraZeneca and Oracle Outline AI Collaboration for Clinical Trial Recruitment and Safety Monitoring
What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
The 10 Most Powerful Study KRIs in RBQM and GCP Issues They Can Prevent
2
From Complexity to Endpoint Meaningfulness: Addressing Key Neuroscience Trial Challenges with eCOA
3
Comparing OpenAI and Mistral on Clinical Trial Matching
4
What FDA Inspections Reveal About the Quality of APAC Clinical Trial Sites
5