Delays to study start-up can undermine clinical research timelines and efficiency. All stakeholders should engage in overcoming these delays. In a new white paper, the Site-Sponsor Consortium – comprising leaders from 20 sponsors, CROs, and research sites – advocates for harmonization of Confidentiality Disclosure agreements (CDAs). These pre-negotiated agreements between a sponsor/CRO and a site/institution are an efficient solution, covering confidentiality for future feasibility activities and studies. A CDA template has been endorsed by the Site-Sponsor Consortium.
As an operational bottleneck in study start-up, negotiation of CDAs can create unnecessary friction between stakeholders. “A master CDA – with input and agreement from legal counsel for sponsors, CROs, institutional sites, and commercial sites – would be the most effective tool to expedite study start-up,” says Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, at Advarra. “Efficiencies in time, money and other resources set the scene for better relationships between sites and sponsors.”
“There are many opportunities for change and we need to start somewhere,” states Michelle Rowe, RN, VP, Research, HCA Healthcare. “Larger sites or groups of sites typically have access to legal advice, while smaller ones may not. Having standardized contracts could be instrumental in enabling more sites to participate in clinical research, serving patients better. Small sites in particular should feel comfortable signing standardized contracts that have been reviewed by experts across stakeholder groups.”
“We’d like sponsors to take a step back and identify ways to become more efficient and faster, taking a global approach,” explains Carlos Orantes, Chief Executive Officer of Alcanza Clinical Research. “Contracts should reflect sites’ overall relationship with the sponsor rather than using transactional approaches tailored to each study, site and Principal Investigator. At present, we have a combination of legacy systems and individual sponsor technologies that are imposed on sites. A standard approach across the industry would be ideal, saving effort for everyone.”
Streamlining Confidentiality Disclosure Agreements to Accelerate Clinical Research
Join Carlos, Michelle, Christine, and Brandi, at ACRP 2026 [April 24-27; Orlando, Fla.] as they share insights into the practical steps needed to reduce study startup timelines and foster a culture of shared responsibility, transparency, and innovation in clinical research. View complete schedule.
“If a contract is pre-approved, then this part of the start-up process would be much quicker, perhaps being completed within a day rather than over several weeks or even months,” notes Orantes. “A more rapid process would speed the site’s decision on whether to do the trial. This would meet sponsor needs to have rapid feedback on sites interest as part of feasibility.”
“Simplifying and standardizing CDAs can remove a source of operational inefficiency, overcome a roadblock, and save time and effort during study startup,” concludes Brandi Walker, Head of Clinical Operations at Syneos Health. “This can in turn accelerate development of new therapies for the patients who need them.”
Edited by Jill Dawson
