Advarra Regulatory Software

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.

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.