Advarra eReg is a Web-based regulatory binder system that integrates with OnCore to sync updates across platforms. It replaces legacy systems involving hard copies by providing digital storage and management of essential regulatory documents that are typically maintained by regulatory coordinators. With eReg, regulatory coordinators can track document owners and expiration dates and route current documents for signature.
Designed for institutions managing a large volume of clinical trials, eReg is a powerful tool for managing regulatory compliance, allowing users to increase their productivity with electronic signatures, delegation of authority, and other features. eReg is a flexible system that supports both in-person and fully remote coordination and monitoring, all in an environment that complies with 21 CFR Part 11 to create secure, audit-ready study binders. With eReg, regulatory coordinators can eliminate duplicate workflows by creating protocol-ready templates tailored to specific types of clinical trials — as well as by creating optimized workflows to minimize time and effort.
eReg will be available to the same research personnel who have regulatory coordinator roles in OnCore, but in most cases access will be limited to assigned protocols.
eReg will serve as the regulatory management system for non-oncology studies only, and oncology studies will continue to use Florence eBinders for compliance processes.
eReg and OnCore will have the ability to sync changes through a central hub, allowing users to work within their system of preference. However, regulatory coordinators are encouraged to use the eReg system as much as possible to take advantage of its delegation of authority processes, e-signature automation and other features.