Medidata Remote Source Review is a cloud-based solution enabling remote monitoring of clinical trials, optimizing document workflows, and ensuring compliance.

Key Features

Submission & Review Structured processes for document submission and review.

• Supports Source Data Verification (SDV) and Source Data Review (SDR).
• Mobile device upload options.
• Automated patient entry when integrated with Rave EDC.

Workflow Management Efficient task and document routing.

• Intelligent task management with conditional logic.
• Standard reports for task management and status updates.

Security & Compliance Ensures data protection and regulatory adherence.

• 21 CFR Part 11-compliant system.
• Built-in redaction functionality for PII/PHI protection.
• Full audit trail for compliance tracking.

Integration with Medidata Platform Seamless integration with other Medidata solutions.

• Single sign-on via iMedidata.
• Automated workflows and data synchronization with Rave EDC.

Benefits

Cost Efficiency Reduces travel expenses and site preparation time.

• Eliminates on-site visit costs for SDV/SDR.
• Streamlines document acquisition processes.

Enhanced Compliance Ensures regulatory compliance and data integrity.

• Automated document removal post-review.
• Comprehensive audit logs for verification.

Improved Clinical Trial Oversight Provides real-time visibility and control over trial activities.

• Standardized reporting tools for better oversight.
• Immediate access to electronic documents upon upload.

Reduced Site Burden Simplifies preparation for monitoring visits.

• Automated workflows minimize manual data entry efforts.