As academic medical centers (AMCs) continue to manage increasingly complex clinical trial portfolios, regulatory compliance remains a cornerstone of operational excellence and sponsor trust. With growing pressure from regulatory authorities and sponsors to demonstrate audit readiness, data integrity, and streamlined oversight, the need for modern eRegulatory solutions has never been greater.
At Cosmos Clinical, we recognize the unique challenges academic sites face—multiple departments, diverse investigator teams, high protocol variability, and limited administrative resources. Our AI-powered eRegulatory platform is designed to meet these challenges head-on, enabling seamless compliance while improving operational efficiency.
Here are five critical eRegulatory features that academic medical centers should prioritize in 2025 and beyond:
1. Auto-Versioning & Real-Time Audit Trails
Maintaining version control across protocols, informed consents, and other essential documents is non-negotiable. Cosmos Clinical automatically tracks document versions and changes, while maintaining secure, time-stamped audit trails. This ensures that regulatory bodies, sponsors, and monitors always have access to the most current and compliant documentation.
2. Centralized, Role-Based Document Access
Siloed systems can compromise oversight and lead to inefficiencies. With Cosmos, academic research teams—regardless of department or location—can access relevant documents in a secure, centralized environment. Role-based permissions ensure that each user sees only what they need, enhancing both security and collaboration.
3. Remote Access for Monitors and Inspectors
Site monitoring visits and regulatory inspections no longer need to disrupt daily operations. Cosmos enables read-only, time-bound access for monitors and auditors, supporting secure remote document reviews without compromising confidentiality or system integrity.
4. Automated Delegation of Authority (DOA) Logs
DOA logs are often a source of inspection findings due to manual errors or outdated entries. Cosmos streamlines this process by automatically linking delegation logs to staff roles, training status, and protocol assignments—keeping records accurate, up-to-date, and always inspection-ready.
5. Integrated Compliance Alerts and Credential Expiry Tracking
Staying on top of expiring certifications, licenses, and training records can be a manual burden. Cosmos automates alerts and reminders, giving academic centers a proactive way to avoid compliance gaps and ensure continuous readiness.
Designed for Academic Research, Built for Compliance
Regulatory compliance is no longer just a requirement—it’s a competitive differentiator. With increased scrutiny from sponsors and regulators, academic sites must adopt technologies that not only ensure adherence but also position them for growth and greater study opportunities.
Cosmos Clinical offers a comprehensive, GCP-ready eRegulatory solution that simplifies compliance, reduces administrative overhead, and supports scalable research operations.