In the evolving landscape of clinical research, regulatory compliance is non-negotiable. Historically, research sites relied on physical binders, paper logs, and manual filing systems to manage essential documents. But with the growing complexity of studies and increasing oversight from regulatory bodies, paper processes are no longer efficient—or compliant enough.
Enter the COSMOS Clinical eRegulatory (eReg, rBinder) System—a digital platform designed to centralize, automate, and secure regulatory documentation while integrating seamlessly with COSMOS CTMS. Built in alignment with ICH GCP E6(R3), it ensures that every document, signature, and workflow is audit-ready from day one.
What Is an eRegulatory (eReg) System in Clinical Trials?
An eRegulatory system is a secure, electronic platform for managing all Essential Documents required under ICH GCP. These documents demonstrate a trial’s compliance with protocols, regulations, and ethical standards, and include:
- Delegation of Authority (DOA) Logs
- Training Records and Certificates
- Protocol Approvals and Amendments
- Investigator CVs and Licenses
- IRB/IEC Approvals
- Safety Reports and Communications
With eReg, sites and sponsors can replace bulky binders with a centralized, role-based access system that supports electronic signatures, version control, and automated compliance tracking.
Why ICH GCP E6(R3) Matters
The ICH GCP E6(R3) update focuses on risk-based quality management, data integrity, and digital enablement. For eReg systems, this means:
- ALCOA++ Compliance: Data must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
- Quality by Design: Processes must be proactive in preventing compliance gaps.
- Technology-Enabled Oversight: Digital tools should support remote monitoring and real-time document status updates.
The COSMOS eReg system is designed to meet these updated expectations, ensuring every action in the system is tracked, time-stamped, and retrievable.
Centralized Digital Regulatory Binder
Replace multiple site binders with a single, secure, digital binder accessible to authorized users from anywhere. No more searching through filing cabinets—find what you need in seconds.
Automated Delegation of Authority (DOA) Log
- Digital DOA templates linked to staff profiles
- Real-time updates when team roles change
- Integrated with COSMOS CTMS for instant task assignment
Role-Based Access and Permissions
Ensure that only authorized users can view, upload, or sign specific documents, supporting ICH GCP R3’s emphasis on controlled access.
Electronic Signatures and 21 CFR Part 11 Compliance
- Legally compliant e-signatures
- Secure identity verification
- Automatic date/time stamps
Version Control and Audit Trails
- Every edit and upload is logged
- Historical versions remain accessible for audit review
- Fully compliant with FDA, EMA, and MHRA expectations
Integrated Training Record Management
Track GCP and protocol-specific training completion within the same platform, with automatic certificate storage in the eReg binder.
Real-Time Compliance Dashboards
- View outstanding documents at a glance
- Monitor site activation readiness
- Enable remote monitoring for sponsors and CROs
Seamless Integration with COSMOS CTMS
- Study start-up documents flow directly into study management workflows
- Automated notifications for expiring licenses and training
- Eliminates double entry across systems
Benefits for Research Sites and Sponsors
Benefit | Impact |
Faster Site Activation | Reduce delays from missing documents |
Audit Readiness | Always inspection-ready with complete trails |
Reduced Administrative Burden | Automate repetitive compliance tasks |
Improved Oversight | Real-time visibility for all stakeholders |
Regulatory Confidence | Fully aligned with ICH GCP E6(R3) |
Why COSMOS eReg Is Different
While many eReg systems focus only on storage, COSMOS combines document management, compliance tracking, and operational integration into a single platform. This all-in-one approach allows sites to manage regulatory, operational, and financial workflows without switching between tools—boosting both efficiency and compliance.
As clinical trials become more complex, digital eReg systems are no longer optional—they are essential. The COSMOS Clinical eRegulatory System not only meets the demands of ICH GCP E6(R3) but also integrates seamlessly with CTMS and other study tools, creating a world-class, audit-ready environment.
If your site is still managing regulatory documents with paper or fragmented systems, now is the time to transition to a digital-first approach.
Ready to Modernize Your Regulatory Process?
Book a demo of COSMOS eReg today and see how it can help your site achieve faster activations, complete compliance, and better sponsor collaboration.