Advarra Offers Cloud-Based Secure Document Exchange To Boost Startup

With Advarra's Site-Sponsor Consortium, the new Advarra Cloud system allows end-to-end integration and automatic, seamless exchange of research papers across sites, sponsors, and CROs.

FREMONT, CA: "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," states Denise Snyder, Associate Dean for Clinical Research at Duke University and member of Advarra's Site-Sponsor Consortium. Advarra, the global leader in regulatory review solutions, clinical research technology for sites and sponsors, and research quality and compliance consulting services, has come up with an end-to-end Secure Document Exchange solution within its Advarra eRegulatory Management (eReg) system. Advarra's methodology allows research sites to employ existing technologies and regulatory binder templates while providing more efficient workflows for sponsors and CROs. With newly available features on Advarra's Longboat Platform, Secure Document Exchange enables sites and sponsors to create new efficiencies while utilizing their existing practice management systems for regulatory document management.

"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," adds Snyder.

The Site-Sponsor Consortium of Advarra was essential in identifying Secure Document Exchange capabilities as a crucial opportunity for process improvement. By combining clinical research sites and sponsor technologies, the group of major research sites, sponsors, CROs, and data standards bodies intends to make clinical trials smarter and more efficient. 

In a recent survey by Advarra and the Society of Clinical Research Sites (SCRS), sites found that sponsor-provided solutions intended to facilitate site-sponsor connections considerably raised site burden. Fundamental tenets of the Consortium's ideology include site-centric workflows and an emphasis on standards. Secure Document Exchange implements this idea by employing standards to expedite routine activities and taking a site-centric approach to developing processes that can be expanded across researchers and technology providers.

All regulatory documentation can be handled, signed, and securely exchanged to the appropriate parties for long-term storage within the sponsor's Electronic Trial Master File (eTMF) and the site's Investigator Site File (eReg). These new features integrate eReg with Advarra's Longboat Platform, a system utilized by tens of thousands of clinical research workers at over 14,000 sites in over 60 countries. Secure Document Exchange links these site and sponsor systems seamlessly, removing the need for the site to manually extract documents from one system and upload them to another and maximizing the use of current site technology to speed launch and ongoing site efficiency. While the integration between Advarra eReg and the Longboat Platform is presently live, Advarra's standards-based methodology provides a broader reach across technology providers to extend the objective of connecting site and sponsor systems smoothly.

"We are excited to deliver cloud-based Secure Document Exchange to accelerate startup timelines across the research industry," comments 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."