eReg

Advarra eReg is a 21 CFR Part 11-compliant electronic regulatory document management system designed to help research sites of all sizes move beyond paper binders and streamline their regulatory workflows. Built for academic medical centers, cancer centers, health systems, and multi-site research organizations, eReg centralizes document storage, automates routing, and connects seamlessly with enterprise research systems to save time, reduce costs, and improve compliance.

Trusted by thousands of research professionals, the platform has supported over 50,000 investigators, managed more than 3,100,000 documents, and facilitated over 43,000 remote monitoring sessions — making it one of the most widely adopted eRegulatory solutions in clinical research.

Paperless Document Management

• Eliminate paper binders by digitally storing signed consent forms, contact information, compensation records, investigational new drugs (INDs), and other essential study documents.
• Centralize standard operating procedure (SOP) document storage and management for quick access by internal staff and sponsor monitors.
• Create standard templates for protocol-essential documents tailored to specific study types, including NIH, industry, and EMA studies, for repeated use across protocols.
• Share staff credentials across multiple protocols to reduce duplication of effort.

Routing, Workflows, and Electronic Signatures

• Quickly route documents to the appropriate staff members and automatically alert them when new documents are available.
• Support electronic signatures for protocol documents, delegation of authority, and other regulatory records to boost compliance and efficiency.
• Leverage master delegation of authority capabilities to significantly reduce the time spent routing and obtaining signatures on documents.

Multi-Site Trial Management

• Enable coordinating centers to view and manage protocol documents for all participating sites in investigator-initiated trials.
• Provide centralized oversight of regulatory documentation across distributed research networks.
• Support Secure Document Exchange, allowing all regulatory documents — whether originating with a sponsor or at a site — to be managed, signed, and securely exchanged within the investigator site file (ISF) in eReg.

Remote Monitoring Capabilities

• Allow sponsors and monitors to conduct fully remote monitoring visits and source document verification during a specified time window.
• Provide secure, controlled remote access to regulatory documents for external stakeholders without compromising data integrity.

Enterprise System Integrations

• Integrate eReg with Advarra's CIRBI platform to improve productivity and compliance across the research enterprise.
• Connect with eIRB systems to streamline the flow of regulatory information between IRB and site teams.
• Integrate with OnCore and Clinical Conductor to align regulatory and operational workflows, speeding study activation and helping patients access treatments sooner.
• Connect with internal email systems to support automated notifications and document routing.

eConsent Add-On Module

• Advarra eConsent is available as an add-on module to eReg, designed to keep participants engaged and simplify compliance oversight throughout the consenting process.
• The module is both 21 CFR Part 11 and HIPAA-compliant, providing an intuitive informed consenting experience for both participants and research staff.
• Leverages existing eReg integrations to minimize duplicative workflows for regulatory and operational staff.
• Helps reduce audit findings and optimize the overall quality of the consenting process.

Advarra eReg is delivered through a fully managed, next-generation cloud environment and has achieved ISO 27001:2013 and SOC 2 Type 2 certification, ensuring that data security and compliance requirements are met to the highest standards. Institutions such as Duke University, The James Comprehensive Cancer Center at The Ohio State University, Inova Health System, and the University of Maryland Greenebaum Comprehensive Cancer Center have leveraged eReg to transform their regulatory operations and improve research efficiency.