This study is intended to collect convincing clinical data to demonstrate the safety and performance of a medical device. The EU MDR now emphasizes that the requirements for clinical data are much stricter than before. If a device manufacturer wants to demonstrate that their device is equivalent or superior to similar devices already on the market, they must provide evidence of having full access to the technical documentation on an ongoing basis. This means that EU MDR regulations necessitate organizing their own clinical studies to obtain a CE-mark certificate or to successfully re-certify and maintain their CE-mark.
The study design should be meticulously developed based on a thorough analysis of the intended use, the selection of appropriate physiological parameters as the primary endpoint, and the careful selection of safety endpoints.
To apply data to a full patient population, it is critical to justify an appropriate sample size. A strict mathematical approach should be employed to ensure a sufficient number of patients is included in the study.
A large number of patients (hundreds, sometimes thousands) makes a pivotal study challenging. The selection and qualification of multiple study sites, potentially across several countries, the training of the study team and site personnel, site monitoring and communication, device logistics, image/sample logistics, data collection methodology, eTMF assembly, regulatory compliance, CEC/DSMB coordination, Safety Management, and QA—all of these activities require a large team and professional project management.
Pharmaxi is a company that manages more than 50 projects and conducts full-scale clinical studies, covering all necessary activities to achieve the final results. We deliver professional solutions designed to minimize the workload on your experts.
