Outsourced clinical investigation: legal aspects

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.

Navigate through our knowledgebase

Related articles


Regulatory pathways for clean meat in the EU and the US – differences & analogies

Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear. This blogpost reports these analogies and differences, based on the agreement that the FDA and USDA recently concluded on their cooperation in the field of clean […]


Cannabis derived food products – what’s the current state of play?

Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products…

Read more


What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]