Department of Clinical Research

Clinical research of drugs is an integral part of the development of medical science and practice. The Ministry of Health of Ukraine singles them out as one of the strategically important areas of activity. Therefore, the Department of Clinical Research was created in the CNPE “Kyiv City Clinical Hospital #1”, which for 26 years has remained a leading research center not only in Ukraine, but also in the world.

The Department of Clinical Research was created to improve the quality of medical services, carry out scientific research, implement modern methods of treatment and diagnostics, promote the development of science, and provide doctors with the experience of using the most modern technologies in the treatment of diseases.

Our specialists:

The staff of the Department of Clinical Research has many years of experience and a high level of skills in the organization and conduct of clinical research in accordance with international quality standards (Good Clinical Practice - GCP). Investigators are experienced with EDC, eCRF, IVRS, ePRO, portals and data upload for central reading.  We maintain a comfortable and spacious area for site monitoring with internet connectivity, convenient retrieval of subject records, source documents, and eCRFs.

Olena KARPENKO - Head of Department

Principal Investigator, Therapist, PhD

Oleksandr KARPENKO

Principal Investigator, Cardiologist, PhD, 

Honored Doctor Of Ukraine

Svitlana SKYBALO 

Investigator, Gastroenterologist

Oleksii DOLKO

Investigator, Therapist

Hanna HERMANOVYCH 

Investigator, Therapist

Liudmyla TODORIUK 

Investigator, Cardiologist

Svitlana KIZIM 

Investigator, Cardiologist

Polina KLIMKO 

Study Nurse, Pharmacist

Areas of clinical research:

Over 150 international randomized clinical trials have been conducted based on the Department during its existence. Today, the areas of clinical research based on the department are:

• Therapy/ Internal diseases

• Infectious diseases / COVID-19

• Vaccination

• Gastroenterology

• Proctology

• Nephrology

• Endocrinology

• Cardiology

• Cardiac surgery

• Interventional cardiology

• Neurology

• Vascular surgery

• Ophthalmology

• Pulmonology

• Surgery

Infrastructure and equipment:

The Department of Clinical Research is equipped with technologies to ensure a high level of scientific research. The department has freezers with adjustable temperature regimes of -20°C and -80°C, a pharmaceutical cabinet and the necessary metrologically tested equipment.

To ensure safety and control, the department uses 24-hour video surveillance and a temperature monitoring system that ensures stable storage conditions for laboratory samples and drugs.

All this creates a high-tech environment that contributes to the successful conduct of clinical research and obtaining accurate and reliable results.

Ethical standards and protection of the rights of research participants

In the process of conducting clinical research, it is important to adhere to ethical norms, high standards of safety and quality to ensure the trust of the participants and the validity of the results.

Each research participant receives accessible information about the scope and purpose of the research, possible risks, and benefits, and has the right to confidentiality.

In accordance with ethical obligations, an Ethics Committee was created based on the Department, which is responsible for the analysis and assessment of ethical aspects of each clinical study. The commission is also responsible for checking and approving research protocols, ensuring their compliance with ethical norms and standards of clinical practice (GCP).

Thus, we adhere to high ethical standards and ensure transparency and openness in our relationships with research participants to ensure a high level of trust and effectiveness in our research work.

Cooperation and partnership:

Cooperation with pharmaceutical companies and contract research organizations (CROs) is an important element in conducting research. The collaboration includes stages from research planning and design to financial support, equipment, and medical expertise.

The Department of Clinical Research cooperates with the following companies:

• "Bayer AG", (Germany);

• "Amgen", (USA);

• "Pfizer", (USA);

• “Eli Lilly and Company”, (USA);

• "AbbVie", (USA);

• "AstraZeneca", (Great Britain);

• "Novo Nordisk", (Denmark);

• "IQVIA", (USA);

• "Parexel International", (USA);

• "Syneos Health", (USA);

• "LabCorp" - (now Fortrea), (USA);

• "Janssen Pharmaceuticals" - (now Johnson & Johnson Innovative Medicine), (USA).

Conclusion:

The Department of Clinical Research of the CNPE “Kyiv City Clinical Hospital #1” is a research base and an organizational and methodological center for research conducted in various directions in the centers and departments of the hospital.

Contact Information:

The Department of Clinical Research is located on the 8th floor of the hospital's medical and diagnostic building (building B), and is open from 9:00 a.m. to 5:00 p.m.

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