Every Clinical Trial is Unique.

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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