Bioclinica has introduced a specialized program for the adjudication of adverse events that could result from COVID-19 infection. Bioclinica’s new program provides an out-of-the-box Clinical Endpoint Committee solution. This solution combines world-class medical expertise, an experienced adjudication management team, and a cutting-edge endpoint adjudication platform to help pharmaceutical and medical device researchers discern COVID-related adverse events from those not associated with COVID-19.
“For ongoing clinical trials that might be impacted by COVID-19, we recognize that time is of the essence. COVID-related maladies can significantly confound the safety analysis of ongoing clinical trials,” said Dan Gebow, senior vice president of research and development, Bioclinica. “As a company founded and led by scientists, we understand the importance of having the best research tools at our fingertips – especially when adapting to a rapidly changing landscape as we are experiencing during this pandemic.”
Bioclinica’s COVID-19 Clinical Adjudication Solution is designed to quickly evaluate a clinical trial protocol and charter to determine if novel COVID endpoint adjudication pathways should be added. Researchers can elect to utilize Bioclinica’s pre-programmed COVID Source Document collection system, COVID Adjudication Pathways, and expert adjudicators, or they can customize each component to best suit their trial.
Bioclinica’s expert physician adjudication network was formed in partnership with C. Michael Gibson, M.S., M.D. of Boston Clinical Research Institute (BCRI) and Harvard Medical School. The network consists of experienced adjudicators from Cardiology, Pulmonology, Neurology, Hepatology, Gastroenterology, and other specialties impacted by the deadly virus.
“The COVID-19 pandemic has given rise to a new specialist, the ‘Covidoligists’ who are adept at diagnosing and caring for a new constellation of inflammatory, infectious, and thrombotic complications affecting many organ systems,” said Dr. Gibson.
“We felt we were in a unique position to assist our fellow researchers, as our team can offer adjudication services and cloud-based software under-one-roof,” said Dr. Gebow. “COVID-19 adds significant risk for pharmaceutical and medical device clinical trials by confounding important safety endpoints. Our solution minimizes that risk by eliminating the need to patch together various endpoint adjudication services, expertise, and software from multiple disparate sources.”
Bioclinica’s COVID-19 Adjudication Solution can be used as a standalone solution for new research studies or as an add-on to ongoing studies. Moreover, as new trials launch that specifically focus on COVID-19 detection, treatment, and surveillance, Bioclinica’s COVID-19 Adjudication Solution efficiently facilitates adjudication of resulting adverse events.