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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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Secure Document Exchange: Connecting the Research Ecosystem

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) or sponsor electronic trial master file (eTMF). Read about our approach and how industry-wide collaboration is the key to finally solving this longstanding challenge.
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secure document exchange

Advarra eReg by the Numbers

Documents managed within Advarra eReg
Remote monitoring sessions conducted through Advarra eReg
Investigators supported by Advarra technology solutions

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.

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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.

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eReg FAQs

Is Advarra eReg 21 CFR Part-11 compliant?

Yes. Advarra eReg is tested and internally validated against 21 CFR Part 11 requirements and is a 21 CFR Part 11-compliant system. Advarra provides a comprehensive packet of validation materials to incorporate into your validation process to reduce the testing and documentation burden for your team. 

Does eReg integrate with any other products?

Yes. eReg integrates with our OnCore Enterprise Research System, Clinical Conductor CTMS, the Advarra Center for IRB Intelligence (CIRBI) Platform, local eIRB systems, and email clients. Any future integrations will be based on the input of our eReg customer collaborators.

How long does it take to implement eReg?

The product is hosted by Advarra, and requires minimal customer IT resources for implementation. This streamlines the implementation process and allows you to see value from the system in a very short timeframe.

Does eReg support remote monitoring?

Yes. The eReg system allows regulatory staff to generate a unique monitoring user and login, indicate the specific protocol document and information to be reviewed, and control the start and stop points for the monitoring session.

What types of research organizations should use eReg?

Advarra eReg is built to support regulatory management workflows for any size site, including academic medical centers, cancer centers, independent research sites, site networks, hospitals, and health systems. Anyone from a small site evolving from paper processes up to a large institution looking to improve overall efficiency and return on investment (ROI) will benefit from Advarra eReg.

Advarra Solutions:

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