eConsent

Medrio eConsent is a web-based electronic informed consent solution designed to streamline all aspects of the informed consent process for clinical trials. It enables study teams to manage participant consent digitally — whether onsite, remotely, or through a hybrid approach — reducing site burden while improving participant comprehension and regulatory compliance. The platform is suited for organizations across medical technology, biotechnology, pharmaceuticals, CROs, consultants, and animal health sectors.

As part of Medrio's unified clinical data platform, eConsent integrates seamlessly with Medrio's CDMS/EDC and other clinical systems, providing real-time visibility into consent status and supporting workflow logic and eligibility checks across the full study lifecycle.

Core Capabilities

• Supports electronic and paper-based consent processes simultaneously, allowing hybrid and virtual consenting approaches
• Enables participants to review and sign consent documents in-clinic, remotely on their own devices, or through a hybrid model
• Allows upload of wet-ink signed paper consent forms into the digital workflow for sites that require paper-based processes
• Captures electronic signatures from multiple sites and participant signatories
• Supports dynamic consent flows, version control, and re-consent management when protocol changes require updated participant authorization
• Provides built-in consent and IRB-approval statuses and dashboards for hassle-free tracking and study oversight
• Automates participant consent requests and site document assignments to reduce site workload

Participant Comprehension and Engagement

• Enhances participant understanding through interactive multimedia content including videos, images, diagrams, and illustrations
• Incorporates comprehension quizzes and FAQ sections to support informed participation
• Participant-centric design supports improved engagement and retention compared to traditional paper forms
• Flexible, intuitive interface prioritizes the participant experience while accommodating site needs

Regulatory Compliance and Data Integrity

• EU-compatible and 21 CFR Part 11-compliant solution that meets ALCOA++ standards
• Captures time-stamped electronic signatures with full audit trails and role-based access controls
• Provides secure storage of consent forms and supports inspection readiness and traceability
• Version control and tracking maintain compliance throughout the study lifecycle
• Real-time data capture ensures consent status is visible to sites and study teams at all times

Workflow and Operational Benefits

• Streamlines the consenting process to reduce site workload and improve data accuracy
• Accelerates study enrollment by enabling flexible, remote participation
• Supports download and printing of unsigned consent forms as needed
• Collects eConsent across geographies with different regulatory requirements, enabling process customization
• Integrates consent status with broader clinical trial data to drive workflow logic and eligibility checks
• Enables mid-study updates with minimal workflow disruption for sites

Medrio eConsent is delivered as a fully integrated component of the Medrio clinical data platform, which also includes CDMS/EDC, eCOA/ePRO, RTSM, Clinical Data Services, and Clinical Trial Project Management. Medrio provides onboarding, study setup guidance, best practices support, and ongoing assistance throughout the study lifecycle, with additional resources available through the Medrio Community forum.