Whether or not your study is required to have oversight from a Data Safety Monitoring Board or Clinical Events Committee, these independent boards add a layer of patient protection and credibility to your research. Unfortunately, it can be difficult to identify an objective group of physicians willing to take on your trial.
IMARC has established an extensive network of physicians and specialists to offer comprehensive safety monitoring so you can be confident in your study results. IMARC will manage all administration of safety monitoring, from arranging and documenting meetings to providing Sunshine Act financial reporting.
The DSMB meets periodically to monitor cumulative study safety data concerns and provide recommendations. The CEC investigates individual adverse events and determines an appropriate, objective adjudication of the event so data analysis will always be as robust as possible. IMARC will develop a customized Safety Monitoring plan to guide the management of your DSMB or CEC to ensure members are well-qualified, meetings are handled expertly and documentation requirements are met.