Introduction of Our Center

Gazi University Faculty of Medicine, Department of Pediatric Metabolism Phase 1 Clinical Research Center is the first Phase 1 clinical research center in the field of rare diseases in Turkey, which was established on January 5, 2018, and is the fifth in Turkey and the first in Ankara.

Clinical trials, in which the effects of the candidate molecule on humans are evaluated after preclinical studies, are usually carried out in four successive phases. Phase 1, phase 2 and phase 3 clinical trials are carried out before licensing, and phase 4 clinical trials are carried out after licensing. Phase 1 clinical trials are studies in which the candidate molecule is administered for the first time in humans and are generally conducted with a small number of healthy volunteers.

Our research center, where only the treatments of rare metabolic and genetic diseases are researched and gene therapies are applied, is among the few centers in Europe and the world, and simultaneous studies are carried out with the same passion with international organizations. Our center, where many phase 1 and other clinical studies are carried out, was built with modern and effective infrastructure services at Gazi University Faculty of Medicine, within the framework of the principles determined by the phase 1 center regulations.

In our center established in the Gazi University Faculty of Medicine building; 5 patient rooms, two of which are hepafiltered, examination room, individual interview room, meeting room, recreation room, executive room, research product room, drug preparation room, refrigerator room (-80 and -20 degrees), short and long-term in accordance with gene therapy conditions. archive rooms (with steel door and moisture meter), kitchen, laundry room and pharmacy cabinet.

Our center is located close to the intensive care unit, and the health and safety of the patients participating in the clinical trial is prioritized.

In phase studies; 24-hour patient follow-up is carried out on-site and online with an experienced specialist doctor, nurses who are experts in their fields, personnel and auxiliary advanced technology equipment. In our center, there are all necessary equipment, materials and systems for emergencies, including camera system, central clock system, wireless internet, indoor camera system, emergency call system, central monitor system.

 

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