This 21 C.F.R. Part 11 compliant system provides functionality for imaging data management, clinical data management, image analysis, project management and document management. It is a comprehensive, permission based system that incorporates project teams, user roles, workflows, study timelines and query/resolution. MIRA™ enables ICON to manage clinical trial data in a proactive, well-controlled environment with complete audit trails.
MIRA™ allows users to import, associate, analyse, review and database medical images and associated regions of interest for clinical trials. MIRA™ also retains a centralised and secure repository of medical images associated with a particular clinical trial protocol. Once images are received and databased, MIRA™ allows users to review, annotate images and archive the assessments for the generation of supportive data describing clinical responses.