This study is intended to collect convincing clinical data to demonstrate the safety and performance of a medical device. EU MDR underlines now that requirements for clinical data are much stronger than it was before. If a manufacturer of a device wants to demonstrate their device is equivalent or superior to similar devices already on the market, they have to provide evidence that they have full access to the technical documentation on an ongoing basis. It means that EU MDR regulations dictate a need to organize their own clinical studies to obtain a CE-mark certificate or successfully re-certify and maintain their CE-mark.
Study design should be adequately developed based on the deep analysis of the intended use, selection of the proper physiological parameters as a primary endpoint, and proper safety endpoints selection.
To apply data to a full patient population, the criticality is a justification of a proper Sample size. In order to get a sufficient number of patients, a strict mathematical approach should be employed.
A large number of patients (hundreds, sometimes thousands) make the pivotal study challenging. The selection and qualification of multiple study sites potentially in several countries, 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 those activities require a big team and professional project management.
Pharmaxi is a company that performs multiple (more than 50) projects, and we manage full-scale clinical studies covering all required activities to reach the final result. We deliver professional solutions to minimize the load on your experts.