Informed consent form with digital pen and paper

The whole process is critical but the sponsor has no certainty at all that the IC was signed BEFORE the patient was selected; his full responsibility relies on doctors perfectly respecting the rules. High control responsibility carried by the CRA. The IC topic is systematically audited by the FDA/EMEA/agency.

clin'form Benefits

• Instant IC (best in class solution to ensure compliance to predicate rules)
• Secured system (embedded encryption system)
• Instant consistency checks
• Instant alert if patient selected and no IC signed
• Provide direct status report in an easily readable dashboard
• Allows correct tracing of consecutive versions of IC forms
• Patient’s anonymity fully preserved
• Pay per use cost: no heavy investment; cost adapted to the size of the study