Accelerating Clinical Trials Through Streamlined Confidential Disclosure Agreements And Processes

In this presentation, Dr. Christine Sen, Senior Vice President at Advarra, addresses the persistent challenge of study startup delays by focusing on a primary legal hurdle: the Confidential Disclosure Agreement (CDA). While essential for protecting proprietary information, CDAs often trigger unnecessary negotiations over jurisdiction and bilateral terms, delaying the transition to the more critical Clinical Trial Agreement (CTA).

Dr. Sen introduces the work of the Site Sponsor Consortium, a collaborative group of 20 industry leaders from sponsors, CROs, and diverse clinical sites. To mitigate startup friction, the consortium proposes:

Prioritizing Master CDAs to eliminate repetitive negotiations.

• Utilizing an open-source, mutual master CDA template that remains silent on jurisdiction to bypass common legal stalemates.
• Internal process streamlining to remove redundant administrative steps.

By treating sites and sponsors as equals, the consortium provides a vetted framework to accelerate the "free flow of information," ensuring clinical trials move from the drawing board to the patient more efficiently.