Advarra Connects Research Stakeholders with Site-Sponsor Consortium

Consortium aims to make clinical trials smarter and more efficient by integrating clinical research site and sponsor technology.

(COLUMBIA, MD.) – Advarra, the market leader in regulatory review solutions, clinical site technologies, and research quality and compliance consulting services, today announced the launch of the Advarra Site-Sponsor Consortium. This unique collaboration, beginning with more than 20 leading research sites, life sciences companies, standards bodies, and industry organizations, aims to seamlessly connect site and sponsor technology, addressing key inefficiencies currently experienced across the clinical research ecosystem. The consortium membership will continue to expand over time to ensure this effort mirrors the diverse makeup of the clinical research ecosystem.

The consortium is facilitated by Advarra, whose site-centric, cloud-based practice management for clinical research platform supports more than 50,000 investigators across academic medical centers, health systems, sites, and site networks, as well as 86% of NCI-designated cancer centers, and 70% of top NIH-funded institutions. Site technology has evolved to provide full operational, regulatory, and data management for clinical trials, but often lacks interoperability with similar sponsor systems. As a result, sites are asked to use trial-specific, sponsor-mandated technology, resulting in duplicative, inefficient workflows. A recent survey sponsored by Advarra and Society for Clinical Research Sites (SCRS) found that:

• 86% of sites prefer to use at least some of their own technology solutions to manage and conduct industry trials
• More than 60% of sites reported that existing sponsor-provided e-clinical solutions designed to enable site-sponsor connections actually increased their burden
• 28% of sites spend more than 15 hours per week interacting with sponsor systems
• 68% of sites currently use at least 4-6 sponsor-mandated systems per study

“Research sites have a unique and valuable perspective that we must take into consideration when developing and deploying technology to clinical trials,” said Jonathan Shough, President, Technology Solutions at Advarra and a key advocate for the consortium. “Advarra believes a site-centric, patient-focused approach is needed to solve longstanding process and workflow challenges faced by the clinical research industry. Our strategic relationships with sites, life sciences companies, and CROs put Advarra in a unique position to bring together leaders in the industry, meeting this challenge head-on and building a site-centric connected ecosystem.”

The Advarra-led consortium will address these challenges through improved data standards, process workflows, reporting, and system integration, as well as the implementation of cloud-based software technology. Guided by close collaboration with the Clinical Data Interchange Standards Consortium (CDISC), members will be able to leverage CDISC Standards to amplify the full value of data to bring safe and effective therapies to patients who need them.

“I am always excited for initiatives that bring sites, CROs, and sponsors together to explore better ways of working,” said consortium member Ross Watson, Director of Global Clinical Operations, CSL Behring. “My work as Head of Site Partnerships has shown me the current challenges and impact of the site experience in clinical research. What I believe makes this consortium unique and positioned for success, is its mission towards creating holistic efficiency by ensuring all impacted parties have a voice to drive solutions.”

“I’ve seen many collaborative initiatives over the years, but lack of site input or consistent standards has prevented any attempt from truly having the impact they promised,” said consortium member Brian Sevier, Chief Operating Officer of the University of Florida Clinical & Translational Science Institute and the Director of the Office of Clinical Research. “While we all operate under regulatory standards, we have yet to define and implement technology standards across sites, sponsors, and CROs. With their close partnerships across academia and industry, I believe Advarra is well-positioned to move the needle and bring together a comprehensive group of study stakeholders poised to act on reoccurring and consequential challenges.”

About Advarra

Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Advarra is advancing clinical trials to make them safer, smarter, and faster. For more information, visit advarra.com.

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