SITE TECHNOLOGY
eReg
Think Beyond the Binder
Save money, improve efficiency, and connect to technology across your organization with a 21 CFR Part 11-compliant system designed to adapt to regulatory workflows for any size research site.

Connected, Paperless eRegulatory Management

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.

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.

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.

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.

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 significantly reduce the amount of time spent routing and obtaining signatures on documents.
The Trusted eReg Platform for Research Sites
Improving Document Management and System Integration with Advarra’s Technology
Learn about the impact an institution has leveraged eReg with other Advarra technology and improved document management across the organization. Ashlee Lang, Director of the Office of Clinical Research, speaks to the value of eReg in helping to remove the need for manual document storage and providing integration with OnCore.
Bringing Efficiency to Regulatory Workflows with Streamlined Technology
Emma Barkman, Director of Regulatory Affairs at the University of Maryland Greenebaum Comprehensive Cancer Center, shares how adopting Advarra’s eReg has transformed their regulatory process. eReg has improved efficiency by speeding up study activation and integrating with OnCore, which ultimately helps their patients access treatments sooner.
Connecting Sites and Sponsors
Secure Document Exchange allows all regulatory documents, originating with a sponsor or at a site, to be managed, signed, and securely exchanged seamlessly within the investigator site file (ISF) (eReg). Read about our approach and how industry-wide collaboration is the key to solving this longstanding challenge.
Case Studies

Duke University Prioritizes Advarra eReg’s Site Centric Workflows Within a Connected Research Ecosystem

The James Comprehensive Cancer Center at The Ohio State University Boosts Compliance and Productivity with Advarra eReg

Inova Health System Uses Advarra eReg Workflows and Integrations to Improve Regulatory Efficiency
Advarra eConsent
Reduce Audit Findings and Streamline Your Consent Process
Available as an add-on module to eReg, Advarra eConsent is designed to keep participants engaged, simplify compliance oversight, and optimize the overall quality of your consenting process.
The 21 CFR Part 11 and HIPAA-compliant module provides an intuitive informed consenting process for participants and your staff, while leveraging Advarra eReg integrations to minimize duplicative workflows for regulatory and operational staff.


Advarra eConsent
Available as an add-on module to eReg, Advarra eConsent is designed to keep participants engaged, simplify compliance oversight, and optimize the overall quality of your consenting process.
The 21 CFR Part 11 and HIPAA-compliant module provides an intuitive informed consenting process for participants and your staff, while leveraging Advarra eReg integrations to minimize duplicative workflows for regulatory and operational staff.

Securing Your Data With a Next-generation Cloud Platform
We are committed to the safety and security of your data, delivering technology solutions in an easy-to-use, fully managed cloud environment. 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.

Securing Your Data With a Next-generation Cloud Platform
We are committed to the safety and security of your data, delivering technology solutions in an easy-to-use, fully managed cloud environment. 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.
