eRegulatory Management System

Build a Paperless Regulatory Process with eReg

Think beyond the binder. Save money, improve efficiency, and enhance regulatory compliance across your organization with a 21 CFR Part 11-compliant system designed to adapt to regulatory workflows for any size research site.

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• **Improve your routing and workflows: **Quickly and easily route documents, automatically alert staff when new documents are available, and boost regulatory compliance and efficiency with electronic signatures for protocol documents, delegation of authority, and more.
• **Apply shared documents and records across multiple protocols: **Create standard templates for protocol-essential documents tailored to each study type (National Institutes of Health [NIH], industry, European Medicines Agency [EMA], etc.) to use repeatedly, and share staff credentials across multiple protocols.
• **Easily and securely allow remote access to sponsors and monitors: **Allow monitors to conduct fully remote monitoring visits and source document verification during a specified time using Advarra eReg’s remote monitoring capabilities.
• **Integrate with your enterprise systems: **Improve productivity and compliance by integrating eReg with Advarra’s CIRBI platform, eIRB systems, OnCore, Clinical Conductor, and your internal email system.
• **Expand your remote capabilities, centralize document management, and move beyond paper binders: **Save staff time, effort, and money when easily storing signed consent forms, contact information, compensation records, investigational new drugs (INDs), and more. Centralize your organization’s standard operating procedure (SOP) document storage and management, allowing quick access for internal staff and sponsor monitors.
• **Efficiently and compliantly manage multi-site trials: **As a coordinating center, view and manage protocol documents for participating sites in an investigator-initiated trial. Plus, leverage eReg’s master delegation of authority capabilities to dramatically reduce the amount of time spent routing and obtaining signatures on documents.

Protecting Your Data is our Highest Priority

We are committed to the safety and security of your data and employ the best available technology and practices. Rest assured, when you become an Advarra eReg customer, you’ll be supported by an industry-leading infrastructure providing comprehensive security at all levels. We have received ISO 27001:2013 and SOC 2 Type 2 certification for our technology solutions, ensuring our products, services, and processes meet stringent requirements to enhance security and compliance.

A Purpose-built Clinical Research Cloud Platform

Built upon clinical research best practices, Advarra Cloud is a next-generation platform delivering applications in an easy-to-use, fully managed environment. Learn how the Cloud can help you automate, connect, and expedite processes across the clinical trial lifecycle.