Strategic Contracting for Clinical Trial Dominance

In her presentation at the recent COG New England meeting, Lynn Agata, the Director of Contracts at Vor Bio, shared insights on strategic contracting for clinical trial dominance. Lynn emphasised the importance of effective contract lifecycle management, focusing on key aspects such as budget negotiation, subject injury clauses, indemnification, insurance, and publication rights.

Lynn Agata, Director of Contracts at Vor Bio

One of the main takeaways from Lynn's session was the significance of collaboration between sponsors and sites. She highlighted that reducing back-and-forth email exchanges and engaging in telephone conversations can greatly streamline the contracting process, reminding attendees that both parties are working together to help patients.

She also discussed the use of Fair Market Value (FMV) tools as a starting point for budget negotiations, along with the consideration of previously agreed-upon fees for similar studies. Stressing the importance of maintaining adequate insurance coverage for the study and ensuring compliance with FDA regulations, such as 21 CFR Part 11 for electronic records and signatures and 21 CFR Part 50 for the protection of human subjects.

Another critical aspect covered in the presentation was the adherence to the General Data Protection Regulation (GDPR). Agata emphasised the need for data processing agreements (DPAs) and the protection of study subjects' personal data through informed consent forms (ICFs).

Lastly, Lynn advocated for the use of a robust contract lifecycle management (CLM) platform to make the end-to-end process of drafting, negotiating, and executing clinical trial agreements more manageable. By leveraging technology and following best practices, organizations can streamline their contracting processes and maintain a competitive edge in the clinical trial landscape.