Medidata Remote Source Review is a cloud-based solution designed to streamline clinical trial operations through remote site access and monitoring. It enables monitors to acquire critical documents remotely, automates document workflows, and supports Source Data Verification (SDV) and Source Data Review (SDR) for compliance and quality. This solution is a key component of remote monitoring strategies, optimizing Risk-Based Quality Management in clinical trials.

Key Features

Submission & Review Structured submission process with prespecified workflows

• Mobile device upload options
• Automated patient entry when connected to Rave EDC
• Preconfigured query text for site/monitor communication

Workflow Management Intelligent task management and document routing

• Conditional logic for task assignment
• Standard reports for task management and status updates

Security & Compliance Robust security measures and compliance features

• Automatic redaction functionality
• 21 CFR Part 11-compliant system
• Full audit trail and documentation

Benefits

Cost Savings Reduces expenses associated with on-site monitoring

• Eliminates site travel and per diem costs
• Decreases time spent on document preparation

Improved Efficiency Streamlines clinical trial management processes

• Expedites document and data review time
• Automates document workflows and task management

Enhanced Data Quality & Compliance Ensures data integrity and regulatory adherence

• Protects PII and PHI with built-in redaction
• Provides audit-ready documentation and tracking