🗂️ Navigation

Complion eReg

The Leader in eRegulatory & Document Management for Clinical Research Sites.

Visit Website →

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)

Clinical Research Sites Hospitals and Health Systems Academic Medical Centers Cancer Centers

✅ 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

Florence eBinders Veeva SiteVault RealTime-eDOCS

Focuses exclusively on the eRegulatory needs of sites, offering deep functionality in this area compared to broader clinical trial platforms.

💻 Platforms

Web

🔌 Integrations

CTMS EHR/EMR eTMF Single Sign-On (SSO)

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ SOC 2 ✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ 21 CFR Part 11

💰 Pricing

Contact for pricing
Visit Complion eReg Website →