The Electronic Consent (eConsent) Solution from Medrio optimizes all aspects of the informed consent process for clinical trials, allowing participants to provide consent from any location, whether remotely or onsite. This solution captures paper or electronic informed consent forms (ICFs) simultaneously, ensuring assured trial compliance with EU compatibility and 21 CFR Part 11 adherence, meeting ALCOA++ standards. It enhances participant comprehension and retention through the integration of images, video content, quizzes, and FAQ sections. The system automates participant consent requests and site document assignments, significantly reducing the burden on research sites. Its flexible, web-based nature supports both electronic and paper-based processes, prioritizing the patient experience and site needs. Users can efficiently deliver consent forms, capture electronic signatures, and implement in-clinic, remote, or hybrid workflows. The platform's built-in flexibility minimizes workflow disruptions for sites and grants participants more autonomy. It allows for the upload of paper consent, downloading and printing of unsigned forms, and collection of eConsent across geographies with varying regulations, facilitating easy process customization.

Features & Benefits

• Simultaneous Capture: Captures paper or electronic informed consent forms (ICFs) concurrently.
• Assured Compliance: EU-compatible and 21 CFR Part 11-compliant, meeting ALCOA++ standards.
• Increased Comprehension: Enhances participant understanding with images, video, quizzes, and FAQs.
• Workflow Automation: Automates consent requests and document assignments, reducing site burden.
• Flexible Workflows: Supports in-clinic, remote, or hybrid eConsent processes with electronic signatures.