Novagenix
conduct the clinical trials in Hakan Cetinsaya IKU Center, Erciyes University
School of Medicine, Kayseri.
Study
protocol that is written according to the GCP and Turkish Ministry of Health’s
requirements is submitted to Ethical Committtee (EC) of the university. After
getting the approval of EC, the study is started, conducted and completed
according to the timetable which is made by the investigator.
All
tubes for blood samplings, test and reference drug products and other materials
(CRFs, labels, timetables, boxes, etc.) are sent to the investigator before the
beginning of the study.
All
participants are insured by Novagenix.
The
study consist of two run-in period and a washout period.
After drawing, all
blood samples (plasma or serum) are put into -70°C deep-freezers until
shipment. Master and back-up samples are sent to Novagenix in different days and
transportations is achieved in maximum 24 hours.
Once
master samples are reached Novagenix, analytical phase of project is started.