Department of Clinical Trials

Head of the department - Ana Baramidze

 

The department conducts clinical studies in phases I-IV of clinical research. The department fully meets the medical requirements necessary for clinical research, in terms of human resources, biological material safety, and the organization of medical documentation. Based on these services, the sponsor receives a comprehensive package for successfully conducting clinical research under the terms of the signed contract.

The department conducts clinical studies in phases I-IV of clinical research. The department fully meets the medical requirements necessary for clinical research, in terms of human resources, biological material safety, and the organization of medical documentation. Based on these services, the sponsor receives a comprehensive package to successfully conduct clinical research under the terms of the signed contract.

 

The department possesses extensive experience in all areas of clinical research and is staffed with specialists in the field who have unique resources to successfully fulfill all the required criteria for conducting research. This is evidenced by their many years of experience, the trust of leading pharmaceutical companies and contract research organizations, as well as multiple successful inspections by the U.S. Food and Drug Administration (FDA).

 

The advanced position of the Clinical Research Department is determined by the team whose experience in this field is unparalleled. This is evidenced by their participation in various successful projects, the continuous improvement of qualifications in many areas of the medical field, and the full assurance of participant safety under the supervision of an independent ethical committee. The department staff successfully manages the general condition of participants before joining the study, during the screening process, in the active phase of the study, and during the post-study period. Any medical manipulation or procedure is organized at a high level, ensuring complete patient safety and creating a highly comfortable environment to guarantee their successful treatment. It is noteworthy that various departments of the clinic, including radiology, endoscopy, radiation oncology, and others, provide high-quality services not only to the department's participants but also to participants in studies ongoing across various clinics in the country.

 

In the laboratory, it is possible to successfully perform various tests, including complete blood count, biochemical, immunological, bacteriological, and morphological studies, as well as molecular genetic tests. The local pharmaceutical base is equipped with the necessary spaces for conducting research. The sterile and refrigeration areas are subject to strict, continuous temperature control and are equipped with various refrigeration units designed to store medications and other biological materials at specific temperatures (-20°C, -70°C). Notably, the minimal time required for transferring medications from the pharmaceutical zone to the transfer room is sufficient. The proper functioning of these systems is ensured by two backup generators, fully preventing any risk of temperature deviations. The department staff handles all types of medical documentation based on FDA, GCP, ICH, local safety standards, and the basic principles of human rights protection, fully adhering to all relevant standards.

 

Another testament to the efficient operation of the Clinical Research Department is the comfortable working environment equipped with the necessary inventory for monitoring and audit visits.

 

 

 

In the laboratory, various tests can be successfully conducted, including complete blood count, biochemical, immunological, bacteriological, and morphological studies, as well as molecular genetic tests. The local pharmaceutical base is equipped with the necessary spaces for conducting research. The sterile and refrigeration areas are subject to strict, continuous temperature control and are equipped with refrigeration units designed to store medications and other biological materials at specific temperatures (-20°C, -70°C). Notably, the minimal time required for transferring medications from the pharmaceutical zone to the transfer room is sufficient. The proper functioning of these systems is ensured by two backup generators, which fully prevent any risk of temperature deviations. The department staff handles all types of medical documentation based on FDA, GCP, ICH, local safety standards, and the basic principles of human rights protection, fully adhering to all relevant standards.

 

Another testament to the efficient operation of the Clinical Research Department is the comfortable working environment, equipped with the necessary inventory for monitoring and audit visits.

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