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Faber, Daeufer & Itrato, in collaboration with Danforth Advisors, recently presented its third webinar in a series of presentations about working with service providers that support the research, development, and commercial activities of life sciences companies. “Structuring Clinical Trial Agreements - How and Why Sponsors Must Get It Right” focused on what clinical trial sponsors need to know about structuring and negotiating contracts to uphold quality, mitigate risk, and achieve best value.
Faber Senior Counsel Gina Wu resumed her role as event moderator. She began by asking Faber Senior Counsel, Elizabeth Keegan, about the importance of efficiently getting Clinical Trial Agreements (CTAs) in place while still protecting the interests of the sponsor. In her response, Keegan provided strategic considerations when preparing for CTA negotiations, critical issues around choosing the parties to a site CTA, and defined the potential unforeseen consequences of including CROs. Keegan also gave a detailed explanation of the Accelerated Clinical Trial Agreement (ACTA), including some of the problems that sponsors should look out for when using it.
Faber Counsel M. Masaya Seltzer spoke next, offering CTA negotiation points, like specifics around ownership of biological samples, and regarding new ideas and inventions, including negotiations with patent counsels and institutions. He also gave negotiation tips before speaking about confidentiality obligations in CTAs and warning about special Institutional Review Board communications, proprietary classifications, and HIPAA liability.
Mariya Pinskaya, Senior Director of Clinical Business Operations at Danforth, and Denise Stearns, Director of Site Contracts at Danforth, both spoke about the effective negotiation of clinical trial budgets to meet funding needs while also successfully carrying out trials in a quality manner. Pinskaya talked about the importance of fair market value and warned against incentivizing sites improperly. She discussed factors that should be considered when determining fair market value and offered tips on preparing adequate and customized budget templates.
Stearns also discussed fair market value, and spoke about industry tools that can be utilized to assist with budget drafting. She gave tips for winning negotiations with favorable terms before discussing sponsor parameters and negotiations around those parameters. Stearns also offered her thoughts on finalizing site level budget templates and provided a list of ten negotiation pitfalls.
Tony Carita, Managing Director of Clinical Business Operations at Danforth, concluded the webinar with a discussion about the sequence of events for getting a site activated and the importance of lead times. He also offered advice on calculating reasonable advanced payments and the questions that should be asked around them.
Faber, Daeufer & Itrato is a dynamic and diverse transactional law firm providing customized business counsel to life science clients in the United States and globally. Danforth Advisors partners with life science companies to provide strategic advisory support to life sciences that include all typical GNA functions ranging from financing and accounting to human resources, insurance and risk management and the outsourcing of clinical programs. The link to the webinar is available at Structuring Clinical Site Agreements (May 25, 2023) on Vimeo.