Clinical Trials of Medicinal Products

      Megainpharm GmbH is experienced in clinical trials management within the territory of Russia and the European Union. We cooperate with numerous licensed clinical centers in order to design the most effective clinical trials plan complying with target product profile, all existing laws, regulations and reference documents.

Clinical trials of a medicinal product are the most important step of product research process, that often defines if the Marketing Authorization is granted to the product or not. Ordinarily, clinical trials are arranged in three phases conducted at licensed clinical centers in volunteers, meeting predefined research criteria (sex, weight, age, ethnicity etc.) under their written consent to participate in clinical trials. Normally, in phase I of clinical trials, a pharmaceutical product is tested in few dozens of healthy patients. Primary goal of this phase is to establish an accurate safety profile and reveal different adverse and side effects. In phase II of clinical trials, a pharmaceutical product is tested in patients with diagnosed disease that is intended to be treated by the medicinal product being studied. Upon completion of this phase, the most accurate medicinal product efficacy profile is established, effective dose, administration schedule and treatment duration are defined. Phase III is carried out in order to collect supportive data on medicinal product efficacy, selected strength, administration schedule and routes in the most diverse group (by sex, age etc.) that usually includes up to few hundreds of test subjects. A report is prepared on the basis of phase III results, supported by scientific and statistical data on product efficacy that serves as basis for final decision-making on granting Marketing Authorization to the product. In certain cases, it is permissible to adjust the procedure, for instance start of clinical trials with phase II, adaptive trial design for phase I/II. However, any changes should be justified, reviewed and approved by relevant competent authority. Clinical trials are considered completed, if the medicinal product demonstrates observable, statistically significant and scientifically-based therapeutic effect, exposing no potential harm.

Megainpharm GmbH offers the following services::