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).
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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
