It plays an active role in the planning, execution and reporting of the phase I-III studies carried out in order to obtain bioavailability/ bioequivalence studies and pharmacokinetic (PK)/ pharmacodynamic (PD) data that support the research and development studies of the pharmaceutical industry.

Mobirise Mobirise

Novagenix on-site conducted clinical trials first year of work organizations a single center in Turkey, which and processes in various foreign authorities (Germany, South Africa, Austria, Spain) also audited, the "Erciyes University Medical Faculty Hakan Çetinsaya HR Center-Kayseri" and began to be carried out; With the opening of "FARMAGEN Clinical Research Center-Gaziantep" in 2009, studies continue to be conducted with both clinics.  

Regarding the clinical trial planned to be conducted;

• Project management
• Establishing the study design
• Preparation of a Clinical Protocol in line with the Turkish Ministry of Health, EMA / FDA regulations and ICH requirements
• Preparation of documents such as Case Report Form (ORF), Informed Consent Form (BGOF)
• Insuring the participants
• Following the processes by making the necessary applications to the Ethics Committee and the Ministry of Health of the Republic of Turkey
• Planning all processes related to work and creating a work schedule
Monitoring of clinical processes when necessary regarding the study
• Preparing the labels of test and reference products, blood collection, transferring serum / plasma / biological material tubes to the clinical center and
• Organization and supervision of sending samples
• After the completion of the work, making the necessary applications and notifications
• An active role is taken in all processes of the clinical trial.



Novagenix Biyoanalitik İlaç Ar-Ge Merk. San. Tic. A.Ş.
Esenboğa Yolu
(Özal Blv.) No: 758 06750
Akyurt / Ankara - TURKEY


Phone : +90 (312) 398 10 81 
Fax : +90 (312) 398 07 18

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