Clinical trials are medical research procedures involving people. They are performed with human volunteers or patients in order to evaluate the safety and efficacy of a candidate medicinal product.
It is a highly regulated, long, risky and time-consuming process and requires precision and multidisciplinary professionality.
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.
Clinical research trials are divided into four (or five) phases (phase (0) I–IV) depending on the nature of the pharmaceutical. The next (following) phase of the clinical trial cannot start as long as the previous one has not proven safety and efficacy of the pharmaceutical.
Phase 0: tests medicinal product safety for humans
Phase I: detects the maximal safe dose of the test medicinal product in healthy humans
Phase II: tests medicinal product when patient receive the test medicinal product for the first time
Phase III: compares test medicinal product to established standard treatment in patients
Phase IV: tests efficacy and safety over long period of time in a large number of patients
With more than 25 years’ experience of successfully completed clinical trials on medicinal products, we have got a deep understanding to help you conquer the complexities of clinical trials.
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