The development of an effective and low-risk pharmaceutical from discovery to market entry is a long and labor-intensive process. It starts with preclinical laboratory tests in vitro and in vivo.
Once it has been proven that a substance is safe, the Common Technical Document (CTD) must be prepared in accordance with the International Conference on Harmonisation (ICH). This is a mandatory step in the development process of a new pharmaceutical before a clinical trial in humans can even begin. CTD consists of 5 modules, which contain detailed information about formulation and pharmaceutical quality up to the results of in vitro and in vivo efficacy tests, toxicity studies, pharmacokinetics, bioavailability, and possible environmental hazards.
Only after the European Commission has approved the document can a Phase I clinical trial according to the Medicinal Products Act (AMG) begin.
Every preclinical study is unique, like every product. We at MEDIACC and our partners can help you complete your documentation and communicate with the relevant authorities to start your study, while you can concentrate on the development of your product.
Shorten the time it takes for the first subjects to include your product at their first visits – call us.
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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