The proprietary MIRA™ system enables clinical data and related images to be posted and viewed by committee members on-line in an electronic and fully 21 CFR Part 11 compliant manner. Data can be “cleaned” prior to posting, which reduces error.

ICON Medical Imaging builds electronic case report forms (eCRF) that link to this and control the presentation of data.  For example, each adjudicator needs to go through each patient on a time point by time point basis sequentially to review events and assess if they are real or not. The eCRF would launch the patient data that may include; the images, lab values, the pdf of an AE report, and the ECG; into the viewer once the reader has logged in.  This data is blinded and identified by a randomised code that has been pre-assigned.  The adjudicator then completes a logically controlled eCRF forcing him or her down a decision tree and ensuring all questions are answered.  At the end the adjudicator confirms the event and electronically signs. 

Every step is recorded and is auditable.  MIRA™ tracks everything, including what data the adjudicator sees.  When this timepoint is "locked", the system closes the information on the screen and brings up all data in the next timepoint.  If extra data is required the case remains held in a queue. This is simple, fast, and easy for the adjudicator.