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Radiant Sage addresses safety and efficacy in clinical trials
BELMONT, Mass.—Radiant Sage LLC, a provider of on-demand clinical trial imaging infrastructure solutions, recently announced its Event Adjudication Committee (EAC) solution for its RadClinica clinical trial management system (CTMS). The new module provides an electronic solution to automate the event adjudication processs, enabling clinical trial sponsors to more quickly identify safety and/or efficacy issues and thus potentially reducing clinical trial costs.
“Event adjudication can be extremely serious. It is critical for trial sponsors to know the effects of a drug or medical device as early as possible during a trial,” said Jesse Bowden, chief operating officer of Radiant Sage. “Event adjudication has been an extremely time-consuming and cumbersome manual process, and communications among the multiple stakeholders has typically been a significant challenge. Our new Event Adjudication Committee solution streamlines the process to allow project staff to more quickly and easily identify, communicate, diagnose and report on events to make necessary safety and efficacy decisions.”
The EAC solution will be offered as an add-on module to the RadClinica CTMS, a single, centralized trial management system to orchestrate operational, financial, contractual and administrative activities.
Said to be seamlessly integrated with RadClinica, the EAC solution acquires all of the required documentation (including images) associated to each event, verifies that the necessary data has been uploaded, initiates the quality assurance review tasks and then enables project managers to create the review package. The system was developed with experienced EAC physicians and sponsor teams to help ensure it met the requirements of actual system users.