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Belmont, Mass. - May 13, 2015 - Radiant Sage LLC, a provider of on-demand clinical trial imaging infrastructure solutions, today 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 process enabling clinical trial sponsors to more quickly identify safety and/or efficacy issues -helping to reduce clinical trial costs and improve the health of individuals.
"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, COO 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. Providing immediate efficiencies and cost savings for clinical operations, RadClinica allows sponsors and service providers to intelligently manage the complexities of multiple clinical trials across multiple sites.
Seamlessly integrated with RadClinica, the EAC solution enables sponsors to easily customize workflows and quality assurance based on specific types of events. It acquires all of the required documentation (including images) associated to each event, verifies that the necessary data has been uploaded, initiates the QA review tasks (i.e. redactions, translation), and then enables project managers to create the review package. The system offers management and reporting tools to provide the entire clinical team oversight of the process.
The highly advanced system was developed with experienced EAC physicians and sponsor teams to ensure it met the requirements of actual system users - eliminating bottlenecks, saving valuable time, increasing the level of efficiency, and producing the necessary metrics to make data-based decisions based on clinical trial events.