Research environment

The potential for conducting Clinical trials in Turkey is enormous with a population of  >70 million and a huge potential with regards to

- Patients and indications (treatment- naive, rare diseases)

- Experienced investigators and site staff , well-trained in GCP

- Fully equipped hospitals, clinics and laboratories accredited for reasearch according to international standards

Actually, about 500 to 600 clinical trials are performed per year.

There are 94 universities, 59 medical schools, 1190 hospitals, 200.000 hospital beds and 95,100 medical doctors, 46% of which have a specialization.

As important advantage Turkey offers are the availability of well- equipped and high level university and state hospitals, well-trained specialized clinicians, lower costs associated with ethical reviews, regulatory approvals and investigator compensation, and a good success rate for patient recruitment.

 

Regulatory and Ethics

As Turkey is a nominee to join the EU in the future, regulations for clinical trials have been modified by the government in DEC 2008, in order to comply with EU regulations (Directive 2001/20/EC).

There is a single (regional) Ethics Committee’s opinion for all sites which dramatically reduces the current timelines, and private hospitals will be allowed to conduct clinical trials, too. EC's and MoH's approval process go in paralell and should not take longer than 60 days.

ICH-GCP has been implemented already a long time ago and compliance with is supervised closely by ECs and the  MoH.

 

Local Partner CRO

Kuantum CRO Ltd. Sti.

I.A.O.S.B. 10032 Sok. No:9

35620 Cigli Izmir-TURKEY

Tel     +90 232 328 35 30

Fax    +90 232 328 35 34

Web    www.kuantum-cro.com

Email  bd@kuantum-cro.com

 

CRO services provided in Turkey

Request for clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, national project management, supply logistics (complete warehouse facilities)

 

Links

http://www.saglik.gov.tr/EN/

http://www.iegm.gov.tr/