Last Wednesday 13 April I spoke at Informa’s 6th Annual Clinical Evaluations and Investigations for Medical Devices conference about legal aspects of outsourced clinical investigation in the medical devices industry.
Proceeding from showing that the CRO, the site, the investigators and the manufacturer have potentially differing interests that the agreement must align the presentation describes how to deal with business compliance issues (anti-kickback and fraud regulation) and regulatory issues. Especially business compliance issues become more and more important because such issues coming up later may not only lead to government action against a company resulting in fines, but may also lead to invalidation of the clinical studies affected if the investigators turn out to have been improperly influenced, and is something that you will not find in ISO 14155, the standard for medical devices clinical trials.
The presentation furthermore gave a detailed roadmap of an agreement for outsourced clinical investigation and a number of drafting tips per clause of the agreement roadmap. Some mechanisms were clarified in more detail, both from CRO and manufacturer perspective such as IP, milestones, termination regime and choice of law and forum.
Finally, I hope to have shown how vitally important it is for a good clinical investigation outsourcing agreement that the regulatory affairs staff and the lawyers concerned approach it as a joint project so the best results are achieved because nothing is overlooked, rather than review the agreement one after the other and assume the other department.