Interested in learning more about how ECLEVAR can create solutions to help you drive healthcare forward?
Alexandre Templier presenting our healthcare solution with Sanofi during Vivatech conference
You are in the right place. Our premarket and postmarket clinical development network makes us the most effective CRO to conduct clinical trials.
More rigorous clinical evidence for Class III and implantable medical devices:
Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims on both safety and performance.
ECLEVAR can support:
Studies leveraging Real-World Data (RWD) can potentially provide information on a wider patient population, thus providing information that cannot be obtained through a traditional clinical trial alone.
Therefore, to prevent potential bias, careful study design is needed, and a study protocol and analysis plan should be created prior to accessing, retrieving, and analyzing RWD, regardless of whether the RWD are already collected (retrospective) or they are to be collected in the future (prospective design).
To meet MDR requirements, device manufacturers should design and run PMCF studies with three major goals: