IMARC Research, a Strongsville, Ohio-based CRO, has launched independent oversight capabilities by adding Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs) to its existing monitoring, auditing, training, project management and consulting services.
IMARC President Sandra Maddock said, “Adding these independent, DSMB and CEC oversight services is a natural progression of IMARC’s existing medical monitoring services and is part of IMARC's 2015 strategic plan.” She added that it also furthers IMARC’s mission to protect human subjects involved in clinical research.
“We have been assembling these safety teams for nearly a year and are starting out with fully operational boards comprised of highly qualified physicians and statisticians in cardiovascular, peripheral vascular, women’s health, renal, emergency medicine, cell therapy and other areas,” Maddock continued. “These services will move IMARC into new therapeutic areas and help us continue to partner with our clients in ensuring human subject protection.”
DSMB and CEC teams help ensure the safety improve the credibility of clinical studies by adding an additional layer of independent safety review of cumulative data and by adjudicating individual safety events.
DSMB review cumulative information from a study and provide safety oversight through recommendations to continue, terminate or adjust a clinical study protocol. CECs provide additional oversight by adjudicating individual adverse events within a study set of adverse events within a study to determine if those events are related to the study product or procedure.