(Columbia, MD) – Advarra, the market leader in regulatory review solutions, clinical research technology for sites and sponsors, and research quality and compliance consulting services, today announced the release of an end-to-end Secure Document Exchange solution within the Advarra eRegulatory Management (eReg) system. Combined with recently released functionality in Advarra’s Longboat Platform, Secure Document Exchange allows sites and sponsors to build new efficiencies while using their own practice management systems for regulatory document management. Advarra’s approach creates the first step in eliminating burdensome manual processes for research sites, allowing sites to leverage their existing technologies and regulatory binder templates, while creating more efficient workflows for sponsors and CROs.
“We are committed to improving administrative workflows and creating efficiencies wherever possible; the implementation of Secure Document Exchange between eReg and sponsor systems is a welcome enhancement that aligns with these goals,” said Denise Snyder, Associate Dean for Clinical Research at Duke University and member of Advarra’s Site-Sponsor Consortium. “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.”
Advarra’s Site-Sponsor Consortium was instrumental in identifying Secure Document Exchange functionality as a critical process improvement opportunity. The group, consisting of leading research sites, sponsors, CROs, and data standards bodies, aims to make clinical trials smarter and more efficient by integrating clinical research site and sponsor technology. In a recent survey conducted in collaboration with the Society of Clinical Research Sites (SCRS), sites reported existing sponsor-provided solutions designed to support site-sponsor connections actually increased site burden significantly. Site-centric workflows and a focus on standards are key pillars of the Consortium’s philosophy. Secure Document Exchange brings this philosophy to life, leveraging standards to accelerate everyday workflows and taking a site-centric approach to building processes that can be scaled across both researchers and technology providers.
“We are excited to deliver cloud-based Secure Document Exchange to accelerate startup timelines across the research industry,” says Jonathan Shough, President of Technology Solutions at Advarra. “This is the first solution released as a result of our unique cross-industry collaboration between sites, sponsors, CROs and data standards organizations. Our customers are sure to translate this integration into meaningful change, and this initial achievement lays the groundwork for many more innovations and improvements ahead.”
These new capabilities connect eReg with Advarra’s Longboat Platform, a system being used worldwide by tens of thousands of clinical research staff, at more than 14,000 sites, in over 60 countries. Secure Document Exchange seamlessly integrates these site and sponsor platforms, eliminating the need for the site to manually download documents from one system and upload them to another, and leveraging the efficient use of existing site technology to accelerate study startup and continuing site efficiency. 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 (eReg). While the integration is currently live between Advarra eReg and the Longboat Platform, Advarra’s standards-based approach enables a wider reach across technology providers to extend the vision of seamlessly connecting 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 on Longboat’s centralized platform
- Support 21 CFR Part 11 compliance across systems
Learn more about Secure Document Exchange