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.
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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