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.
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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.
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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.
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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.
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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.
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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.
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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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.
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.
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.
