Connecting the Research Ecosystem
All regulatory documents, originating with a sponsor or at a site, can be managed, signed, and securely exchanged to the correct parties for long-term storage into the sponsor’s Electronic Trial Master File (eTMF) and site’s Investigator Site File, without requiring either the sponsor or research site to leave their organization’s technology.
While the integration is currently live between the Advarra eRegulatory Management System (eReg) and Advarra’s Longboat Platform, the standards-based approach makes it possible for any technology vendor to seamlessly connect site and sponsor systems.
Secure Document Exchange within Advarra eReg allows sites to:
- Identify and access requested documents and associated required actions
- Receive, sign, and return documents distributed by the sponsor
- Upload and deliver documents originating at the site to the sponsor
- Correspond with sponsors and CROs in a centralized manner
- Ensure compliance with 21 CFR Part 11 across systems
Secure Document Exchange within the Longboat Platform enables study teams to:
- Centrally manage documents and document metadata and enable communications within a centralized platform
- Distribute all necessary documents and metadata to sites globally in a consistent and recorded manner
- Request documents required from sites on a global, regional, or single-site basis
- Track and monitor the status of documents and requests
- Route all relevant documents to the appropriate eTMF throughout the course of a study
We are committed to improving administrative workflows and creating efficiencies wherever possible, and the implementation of Secure Document Exchange between eReg and sponsor systems is a welcome enhancement that aligns with these goals. Document exchange has been a pain point for sites, often resulting in duplicative work and additional training burden for our staff who have to learn a different system for each sponsor. Giving our research teams the ability to leverage the eReg system we already use to share documents with sponsors will be a game-changer, particularly during study startup. We appreciate Advarra’s efforts to create a productive collaboration between sites and sponsors to streamline this critical workflow.
Associate Dean for Clinical Research, Duke University
Site-Centric Workflows for the Success of all Stakeholders
In order to improve the research experience for their own organization as well as others, Duke University turned to Advarra for technology solutions that support site-centric workflows, prioritize site feedback in future developments, and supports connectivity between key trials stakeholders and systems.
Informed by the Site-Sponsor Consortium
Advarra’s Site-Sponsor Consortium, made up of research site, sponsor, CRO, and data standards leaders, aims to make clinical trials smarter and more efficient by integrating clinical research site and sponsor technology.
Secure Document Exchange brings their input and philosophy to life via practical efficiencies across everyday workflows. In addition, its site-centric approach lays the foundation for processes that can be scaled across any vendor system.
The ROI of eRegulatory and eIRB Integration
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4 Reasons Your Institution Needs an eRegulatory System
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