clinical researches are performed in the department of clinical researches, i-iv phase clinical studies. the department fully complies with the medical requirements of clinical studies: in terms of human resources, the safety of biological materials, and organizing medical documentation. by an agreement concluded on the basis of these services, a sponsor gets a comprehensive package for the successful implementation of a clinical study.
the department has vast experience in all aspects of clinical studies and is staffed with specialists in this field, who have unique resources to successfully perform all requirements necessary for conducting a study. this is confirmed by years of experience, trust from the leading pharmaceutical companies and contractor research organizations, and multiple inspections performed by the food and drug agency of the usa. leading positions of the department of clinical researches are ensured by the team, which is unrivalled in this field. it is confirmed by their participation in numerous successful projects, permanent professional development in many fields of medicine, and provision of full safety of the participants in clinical studies under the control of an independent ethics committee.
department employees successfully manage the general conditions of participants before enrollment in a study, in the process of screening, in the active phase of study and in the follow-up period. performance of any medical manipulation or procedure is well arranged, the safety of patients is fully protected and maximally comfortable conditions for their successful treatment are ensured.
it should be noted that various departments of the clinic: radiology, endoscopy, radiation oncology, etc. offer high-quality services to participants of clinical studies, conducted not only in the department, but in other clinics throughout the country too.
the laboratory has capabilities to perform complete blood count, biochemical, immunological, bacteriological, or morphological tests, and various tests of molecular genetics. the local pharmaceutical base is equipped with areas necessary for conducting a study. sterile and refrigerator areas, which are under permanent strict control of temperature, equipped with refrigeration units of various functions, depending on conditions for storage of medications and biological materials (-20 °c, -70°c); it should be noted that the time needed for transport of medication from the pharmaceutical zone to the transfusion room is minimal.
two backup generators ensure the proper functioning of these systems, and they allow to avoid any risk of temperature deviations of any type. the employees of the department maintain any type of medical documentation in compliance with fda, gcp, ich, local safety requirements, and main principles and standards of human rights protection.
one more confirmation of the proper functioning of the department of clinical researches is a comfortable working environment equipped with the necessary inventory, for visits of monitors and auditors.