Bioclinica Adds eConsent to EDC Platform

Bioclinica, an ERT company, added eConsent as part of its Electronic Data Capture and Management suite of products. The new electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions between the site and clinical trial participants.

"As trials become more complex and remote, the need to bring clarity to the consent process is stronger than ever," said Guy Crossley, President of Bioclinica Software Solutions. "eConsent allows sponsors and CROs to expand their reach for a more diverse population and ensures that patients remain engaged as they have a better understanding of what is involved before committing to a trial."

This addition integrates with the Bioclinica platform and is deployable with EDC and Outcomes in as little as eight weeks from protocol delivery, according to the company. The eConsent module includes: multimedia components for participant education/understanding, functionality for questions and comments, ability to manage multiple IRB approvals in one study, management of witness signatures, ability for sponsors/CROs to sign out multiple documents to a single site or subject, and built-in approval workflow for IRBs.