YPrime eConsent is a cloud-based electronic informed consent solution designed to digitize and manage participant consent processes in clinical trials. It replaces paper-based consent forms with interactive, multimedia-enabled workflows that support comprehension, documentation, and regulatory compliance. The system enables sponsors, sites, and CROs to track consent versions, capture electronic signatures, and maintain secure audit records within regulated research environments.

Key Features

Digital Informed Consent Presentation Provides structured, electronic delivery of consent materials.

• Multimedia content support
• Structured section navigation
• Interactive presentation format

Electronic Signature Capture Enables compliant digital documentation.

• Secure electronic signatures
• Time- and date-stamped records
• Signature tracking and verification

Version Control & Tracking Manages consent form updates.

• Automatic version management
• Re-consent workflows
• Document history tracking

Participant Comprehension Support Enhances understanding of study participation.

• Embedded educational content
• Review checkpoints
• Confirmation steps before signing

Role-Based Access & Audit Trails Maintains regulatory oversight.

• Configurable user permissions
• Complete audit logs
• Secure data storage

Integration Capabilities Connects with broader study systems.

• Integration with eCOA and IRT
• Data exchange with clinical data platforms
• Centralized study oversight

Remote & On-Site Use Supports flexible consent processes.

• On-site electronic consent
• Remote consent capabilities
• Multi-device compatibility

Benefits

Improved Participant Understanding Supports informed decision-making.

• Structured presentation of information
• Interactive educational elements

Operational Efficiency Reduces administrative burden.

• Eliminates paper handling
• Streamlined documentation workflows

Regulatory Compliance Supports regulated clinical research standards.

• 21 CFR Part 11 support
• Secure audit-ready documentation

Enhanced Transparency Maintains clear consent history.

• Version tracking
• Re-consent documentation

Faster Study Start-Up Accelerates site activation and enrollment.

• Digital distribution of consent forms
• Centralized consent management

Global Study Support Enables multinational research programs.

• Multilingual configuration
• Localization support