Clinevo eConsent

Clinevo eConsent is a regulatory-compliant electronic informed consent system designed for clinical trials. It is built for pharmaceutical companies, CROs, and life sciences teams that need a patient-friendly, mobile-compatible consenting solution. The system supports decentralized and hybrid study designs and is intended to improve participant engagement, comprehension, and overall consent process quality.

The platform incorporates multimedia components — including audio, video, images, and PDF documents — to create interactive consent experiences that accommodate different learning styles. It is part of a broader clinical trial platform that also includes EDC, IWRS, eCOA, CTMS, eTMF, and remote monitoring capabilities.

Core Features

• Mobile-friendly design compatible with iOS, Android, iPad, laptop, and other devices
• Multimedia support for videos, audio files, images, and PDF documents within consent workflows
• Simple user interface requiring little or no training for participants
• Automated alerts delivered to participants' smartphones to remind them to complete consent tasks
• Real-time dashboards and analytics for monitoring and tracking participant responses and statuses
• Support for decentralized and hybrid clinical trial models

Compliance and Regulatory Support

• Complies with 21 CFR Part 11, Annex 11, GxP, and GDPR requirements
• Includes automated compliance checks and robust audit trails
• Designed to be regulatory inspection ready
• Supports end-to-end process management from initial setup through final reporting

Integration and Technology

• Built on Java technology, enabling integration with various CTMS and EDC systems
• Operates as part of a unified clinical trial platform alongside other Clinevo modules
• Cloud-based infrastructure reducing the need for on-site hardware and manual processes

Deployment and Support

• Includes dedicated infrastructure, hosting, and training as part of the offering
• 24/7 application support provided
• Transparent, optimized pricing model
• Expert support available for implementation, training, and ongoing assistance

Clinevo eConsent is used by life sciences, pharmaceutical, biotech, and CRO clients across the USA, UK, Europe, South Korea, Japan, China, and India. The system is positioned as a cost-effective option within the broader Clinevo clinical trial software suite.