The investigational team of Clinical and Diagnostics Center includes 3 Doctors of Medical (Pharmacy) Sciences, 9 PhD, 4 MD Investigators and 6 trial nurses. All investigators and trial nurses were certified for the highest qualification category. The resuscitation specialists and clinical pharmacists are also included in the staff. Altogether there are 26 persons. The study coordinator provides the coherence of the trial, and quality-control specialist is responsible for the quality of procedures. All investigators have passed clinical trials training courses and have got GCP certifications.
"Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)"..
- The safety of the patients/healthy volunteers
- The healthy volunteers and the patients
- An effective system of clinical trials procedures
The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society (ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.3). In Clinical and Diagnostics Center it is secured as much as possible.
The condition of the patients/healthy volunteers is regularly monitored by the medical staff and enhanced by video-supervision. In case of emergency there is special well-appointed resuscitation unit.
It is equipped with the following facilities: artificial lungs ventilation device, cardiomonitor, defibrillator, kits with instruments and drugs for the emergency medical aid. During the patients’/healthy volunteers’ hospitalization the resuscitation doctors stay night watch by the patient’s bedside together with the investigators/physicians.
The medical care given to, and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician
ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.7
There are more than 500 healthy volunteers in the electronic database of Clinical and Diagnostics Center. During the clinical study the volunteers are accommodated in the comfortable wards which correspond to European level and are equipped with satellite TV, day and night Internet access. Meals for the volunteers meet study protocol requirements.
The organic food is served in strict accordance with the optimal content of calories, proteins, fats and carbohydrates. The esthetic design of Clinical and Diagnostics Center such as summer and winter gardens, voluminous library, video collection, board games improve the volunteers’ stay.
A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Sections 2.2 − 2.3
The whole process of a clinical trial is held in strict compliance with the study protocol and standard operating procedures (SOP) of clinical base. A team of researchers has developed more than 200 SOPs, which are periodically updated and processed.
The structure of the research team included experts in quality control of clinical research. During the study all the procedures are continuously monitored, including through video surveillance.
To ensure a smooth stroke timing of clinical trials in all areas used set of GPS-synchronized electronic clock.
Center is equipped with its own archive, which provides storage of documents in clinical trials within the time specified by the legislation of Ukraine and the GCP requirements.
System procedures should be used to ensure the quality of clinical trials in all its aspects.
ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.13
The results are accepting by EMA & FDA
Results get faster
Easier to find volunteers
EMA audit was conducted