The clinical trial provider, Biomedical Systems, announced the partnership with RadMD, a provider for independent expert physician image reviews for safety and efficacy endpoints.
According to the company, RadMD’s organization of more than 600 enables it to provide clients with imaging clinical trial experience – which it said is important with the increase in oncology trials and reliance on imaging services for efficacy evaluations.
“Independent expert readers such as those from RadMD represent a vital component to providing our clients with consistent and reliable data,” said Bob Mills, CCO, Biomedical Systems, commented in a press release.
Additionally, Mills explained the agreement enables Biomedical Systems and RadMD to collaborate further on clinical trials in addition to augmenting both companies’ imaging capabilities.
Rick Patt and Kohkan Shamsi, Cofounders and Principals of RadMD, explained the company will coordinate study-specific training and performance management.
The two also said the agreement establishes “a new level of comprehensive reader management by RadMD,” as it leverages its team of BRITI-certified (Blinded Reader and Investigator Training Institute) readers.
This knowledge, combined with Biomedical’s electronic case report forms (eCRFs), “will raise the bar on the quality of image interpretations in clinical trials,” Patt and Shamsi explained in the release.
Biomedical Systems did not respond to a request for comment.
Update:
Dr. Rick Patt, Co-founder and Principal of RadMD, told Outsourcing-Pharma.com the goal is to continue to collaborate on imaging opportunities as well as evaluate options to partner on educational, reader management, and marketing initiatives. The company has meetings scheduled to further explore these and other topics, Patt said.
"Using a small group of well-trained, disease experts, and actively managing performance variability ensures the data are interpreted consistently," he added. "Many trials fail or succeed based solely based on independent reader interpretation of the primary endpoint. FDA has flagged and questioned many trials due to both high inter- and intra- reader variability in readers’ interpretations."