Study drug accountability is crucial for monitoring patient compliance and ensuring study data integrity. Accountability should be demonstrated by full traceability of IMP (investigational medicinal product) from initial release, ordering, allocation, and dispensation through return-to-site, accountability, reconciliation, and eventual destruction.
By the means of Genius IMP™, Exom has revolutionized the digital process for collection and tracking of drug accountability and for monitoring compliance in clinical trials.
Starting with printing specific e-labels for study medication unit package, the Genius IMP™ applications, allows a real-time drug accountability and compliance, any time the study drug is dispensed to patient, by a simple scan with any mobile device, of the QR code printed on the e-label.
Through the combination of data from the returned medication with the date and time of dispensation of new medication, the system will immediately calculate the patient’s compliance rate to the experimental drug.
That information will allow, if needed, immediate interventions by the involved investigator.
Real time accountability and compliance data will provide transparency through the entire chain of IMP supply and management and will complement the interpretation of study drug efficacy and safety.