The eClinical technology company released Medrio eConsent to provide clients with an electronic-consent (eConsent) application to accelerate clinical trial processes. The product uses the cloud to enable sponsors and contract research organizations (CROs) to access consent forms instantly.
Medrio eConsent incorporates graphics, videos, quiz modules, and frequently asked questions (FAQ) documents in an aim to increase patient comprehension during informed consent. Patient’s personally identifiable information (PII) will be protected through encryption measures.
After two rounds of Beta testing, in which patients interacted with the app in test environments, the product is set for the market, according to the company..
Beta testing participant and clinical research programmer at the University of California, San Francisco stated in a press release, “An automated process of document versioning and centralized record storage also enables us to ensure that our consenting process is accurate and compliant with both the study protocol and Institutional Review Board (IRB) guidelines.”
The release comes on the heels of the FDA’s guidance on the use of eConsent, and this year’s General Data Protection Regulation (GDPR), which requires the industry to provide a thorough consent process that is ‘comprehensible to the layperson.’
