Complion eReg
The Leader in eRegulatory & Document Management for Clinical Research Sites.
Overview
Complion is a leading provider of eRegulatory solutions for clinical research sites, academic medical centers, and health systems. Its platform is designed to replace paper-based regulatory binders (ISF) with a collaborative, 21 CFR Part 11 compliant electronic system. While it manages IRB-approved documents, it is not a system for the IRB office to manage submissions and reviews. It focuses on site-level compliance and document management.
✨ Key Features
- Electronic Regulatory Binders (eISF)
- 21 CFR Part 11 & HIPAA Compliant
- Electronic Signatures
- Remote Monitoring
- Centralized Document Management
- Automated Workflows and Task Management
- Comprehensive Audit Trails
🎯 Key Differentiators
- Purpose-built for site regulatory management.
- Strong focus on collaboration and workflows between sites and sponsors/CROs.
- Deep expertise in clinical research site operations.
Unique Value: Transforms site regulatory operations from paper to digital, ensuring compliance, improving efficiency, and facilitating remote collaboration and oversight.
🎯 Use Cases (4)
✅ Best For
- Streamlining regulatory document management and enabling remote monitoring for high-performing research sites.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- IRB offices seeking a platform to manage their committee's review and approval process.
🏆 Alternatives
Focuses exclusively on the eRegulatory needs of sites, offering deep functionality in this area compared to broader clinical trial platforms.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Phone Support
- ✓ Dedicated Support (Enterprise tier)
🔒 Compliance & Security
💰 Pricing
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