The ways to increase the efficiency of clinical researches of medicinal preparations in a hematological clinic
Clinical researches of medicinal preparations have been carried out at the Institute since 2001. During 17 years we fulfilled more than 50 international multi-central clinical researches of phases I, II, III, IV estimated to security, efficiency and pharmacological properties of preparations applied in hematology, onco-hematology and oncology and immune-biological preparations on volunteers. Based on the analysis of the clinical researches we distinguish 2 periods. The 1st is up to the year of 2014, when we annually conducted less than 5 researches, the 2nd –from 2014 up to nowadays, when we annually carry out till 15 researches. The obtained results were achieved due to the realization of the following administrative measures: 1. The department of clinical researches was established. 2. The department is provided of premises equipped for the storage of documentation. There are also pharmaceutical refrigerators. There are 4 workplaces with office appliances to provide the activities of monitors and auditors. 3. The approval timeframe and the deadline for signing of Contracts for the conduction of clinical researches does not exceed 7 days. 4. The training of clinical staff for basic principles of GCP is carried out systematically. 5. Middle grade medical staff has completed specialization on the immunization program 6. In case of necessity we invite off-site specialists for the participation in clinical researches. 7. We developed a database of healthy volunteers consisting of more than 300 persons.