At Orange CTM, we understand that maintaining regulatory compliance is a critical—and often complex—part of clinical research.

Our Patient Recruitment & Retention Module not only streamlines enrollment but also helps you stay audit-ready by simplifying document management, tracking, and communication through automation and intelligent workflows.

Digital Regulatory Binder

• Centralized, searchable e-binders for easy access
• Role-based permissions to protect sensitive data
• Version control and document history for full transparency

Submission & Approval Workflows

• Automated IRB/EC document routing and tracking
• Support for digital signatures and e-consent
• Smart alerts for missing or expired forms to avoid delays

Audit-Ready Documentation

• Automatic document date stamping
• Electronic logs for training, deviations, and amendments
• 21 CFR Part 11-compliant digital archiving for secure, compliant record keeping