Advarra's Site-Sponsor Consortium Publishes Industry Report and Master Mutual CDA Template to Streamline Feasibility and Reduce Study Startup Timelines

Cross-Stakeholder Initiative Standardizes Preliminary Confidentiality Practices Across Sponsors, CROs, and Sites

COLUMBIA, Md., Oct. 1, 2025 /PRNewswire/ -- Advarra, the market leader in regulatory reviews and a leading provider of clinical research technology, today announced the Site-Sponsor Consortium's first industry deliverable designed to streamline a common bottleneck in clinical trials: the Confidential Disclosure Agreement (CDA). The industry report Accelerating Clinical Trials through Streamlined Confidential Disclosure Agreements and Processes and a ready-to-use Master Mutual CDA Template promote mutual, efficient confidentiality practices so sponsors and CROs can share protocol materials promptly and sites can begin feasibility without avoidable delay.

Across the research ecosystem, inconsistent CDA practices can add weeks or months of back-and-forth before sites see a protocol. The Site-Sponsor Consortium—an equally weighted coalition of sponsors, CROs, and research sites (including academic medical centers, health systems, and site networks)—recommends master CDAs between sponsors/CROs and sites, bi-directional confidentiality to avoid one-sided negotiations, and electronic signatures to eliminate manual routing. Together, these create a faster, simpler path to feasibility assessments, site selection, and startup planning.

"CDAs should enable conversation, not delay it," said Christine Senn, SVP of site-sponsor innovation at Advarra and chair of the Site-Sponsor Consortium. "When organizations rely on a mutual, master CDA and straightforward workflows, they shorten contract cycles at the outset and devote more time to moving potential therapies toward patients. 'Day zero' truly becomes day zero."

The mission of the Site-Sponsor Consortium is to expedite clinical research by co-creating vendor-agnostic deliverables that drive process efficiency, strengthen collaboration, and dismantle operational silos. By aligning stakeholders around a mutual, master CDA and clear electronic execution, the initiative streamlines early-stage contracting, accelerates protocol review, and brings greater predictability to study startup timelines across programs and studies. With 20 co-authors representing sites, sponsors, and CROs, the guidance reflects a balanced, broadly adoptable, and scalable approach.

"Mutual confidentiality and a master CDA are the difference between stop-and-start outreach and a clean launch into feasibility," said Carlos Orantes, CEO of Alcanza Clinical Research. "It's a practical change with outsized impact on timelines."

The industry report makes the case for simple, mutual CDAs—distinct from the Clinical Trial Agreement—and provides practical guidance on ownership, common pitfalls (such as click-through signatures and entity mismatches), and when a master CDA prevents rework. The accompanying Master Mutual CDA Template applies this guidance to reduce negotiation while preserving protection for both parties' confidential information.

"This is partnership at work: a practical standard that respects site needs and gives sponsors a clearer, faster path from outreach to startup," added Marisa Rackley, VP of study optimization, clinical site startup and site engagement at Takeda. "That clarity helps us collaborate with sites more seamlessly and align on feasibility with fewer cycles."

Both resources are available to access via the Site-Sponsor Consortium page on Advarra's website.

About Advarra
Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions improve collaboration, transparency, and compliance to optimize study design and operations. With unmatched trial operations data, and an ongoing investment in AI innovation, Advarra continues to reimagine what's possible in clinical research. For more information, visit advarra.com.

SOURCE Advarra