There is a lot to consider and discuss in order to do the right thing right from the start.
In clinical studies, the safety of innovations is tested before they can be used as therapies for patients or healthy people in the context of medical progress. Based on many years of experience, we have developed a holistic approach that is as holistic as the treatment that our patients and treated persons can expect from us.
A rough distinction is made between interventional and non-interventional studies. For this there are very different requirements, laws, guidelines and regulations, the detailed knowledge of which is essential.
In addition to the precise assessment of an innovation and its allocation to pharmaceuticals, medical devices including risk classification, dietary supplements or cosmetics, other factors must be considered from the very beginning.
These include knowledge of the present data, assessment of the market and thus the need, the state of the art, the existing therapy options and guidelines. Only then is it worth the effort to plan a proof of efficacy and the benefit or additional benefit with a relevant question for a clinical study.
Other important factors that must be considered in advance are the required level of evidence, clear assessment and positioning of an innovation or selection of a relevant indication area in order to ensure reimbursement by health insurance funds or patients.
We work focused with standardised processes. Please feel free to contact us at an early stage.
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