Strategic Advice and Research Design
Strategic and operational assistance
Through its “Clinical Evaluation of Innovative Devices” department, KYomed INNOV helps you to proceed with your clinical evaluations. “The first step of this support is to assist the client in taking the most appropriate strategic, technological and operational orientations, according to how far the project has advanced, the existence on the market of competing or complementary products, the type of device and its development prospects – in France, in Europe, in the United States… – “, explains the head of the department.
A literature review and rigorous monitoring are essential first steps towards proposing the most pertinent clinical evaluation, one that will convincingly demonstrate the value of the new device and optimize its value. We also locate at an early stage the available data sets relevant to the device as well as any recommendations that may concern it.
Designing the right protocol
Once you have defined your clinical evaluation framework, we will help you write the protocol or clinical investigation plan. “For this, we call on medical experts to design the most appropriate clinical evaluation plan for your device and the positioning you want to give it“, says the head of the department.
What kind of study to conduct? How many patients to include? What criteria to select? In the case of a comparative study, what are the most appropriate benchmarks?… These are all questions that we help you answer in order to arrive at the best research design. In addition, there is a range of forms and documents that are essential to the study (consent, information notice, brochure or technical documentation, etc.) which we can prepare for you or help you write.