Clinical Studies & CRO for medical devices

For many medical devices, clinical investigations are the most demanding part of the route to market — and since the MDR they are needed for more devices than before, because demonstrating equivalence with comparable devices has been narrowed. Running an investigation requires investigational sites, a clinical investigation plan to ISO 14155, approval by the competent authority and the opinion of the ethics committee, plus monitoring, data management and an analysis that will stand up to a notified body.

Contract research organisations, CROs for short, take on this work in whole or in part. The range extends from study design and the submission process through selection and management of sites to biostatistics, safety reporting and the final report. Experience with medical devices is decisive: procedures, regulations and reporting routes differ markedly from drug trials.

The clinical investigation must be distinguished from the clinical evaluation. The evaluation appraises all available data and is mandatory for every device; the investigation generates new data where existing data are insufficient. Many providers listed here cover both — anyone commissioning work should know which of the two they need.