eReg / eISF

eReg / eISF by RealTime eClinical Solutions is an electronic document management and regulatory system purpose-built for clinical research sites and academic medical centers (AMCs). Developed by the pioneers of eDocs and Complion eISF, this user-friendly platform helps sites, sponsors, and CROs eliminate paper clutter and simplify the storage, retrieval, and collaboration of regulatory and investigator site file documents across site teams and departments.

The platform is designed to replace bulky physical folders with a secure, centralized digital environment — giving research teams instant access to the documents they need, from any device, at any time.

Secure, Centralized Document Management

• Secure online document storage protects research data with industry-leading security measures, giving teams peace of mind.
• 24/7 access from any device, anywhere, eliminating the need to search for misplaced documents.
• Version control automatically tracks all document revisions, ensuring teams always work with the most recent and accurate information.
• Advanced search functionality enables users to quickly locate specific documents, saving valuable time.
• Automated expiration alerts proactively notify teams of document renewal deadlines, keeping research compliant and avoiding disruptions.

Compliance and Regulatory Safeguards

• Fully compliant with 21 CFR Part 11, GCP, SOC2, HIPAA, and GDPR requirements.
• Built-in query management system enables seamless collaboration with monitors.
• Supports both on-site and remote access for monitors, auditors, and inspectors.
• Increases confidence during FDA audits and inspections.
• Simplifies remote monitor access and overall audit readiness.

Preferred by Academic Medical Centers

• Secure document sharing with internal and external teams for seamless collaboration and efficient information exchange.
• Streamlined workflows accelerate study execution by eliminating delays caused by misplaced documents or inefficient communication.
• Instant file access keeps research on track and teams productive.
• Standardized naming conventions make documents easy to find, removing the need to dig through spreadsheets, emails, or paperwork.

eReg / eISF is a cloud-based solution accessible from any device, making it well suited for distributed site teams and multi-department academic medical centers. Its compliance with major regulatory and data privacy frameworks ensures that organizations can confidently manage their regulatory documents while remaining inspection-ready at all times.