Country of Georgia has been involved in clinical research over 20 years. During this period, research filed has been expanding rapidly and by now there are hundreds of clinical sites actively involved in clinical research. Oncology and especially breast cancer studies prevail and account for majority of the studies conducted in the country.
Georgia gained popularity among international CROs and Sponsors partly because of simple and transparent regulatory approval process as well as the fact that majority of hospitals involved in the clinical search are privately owned. The former ensures that recruitment is usually highest among the participating countries and the quality of the data is excellent.
Due to this high clinical research activity, it comes to no surprise that FDA has started inspecting Georgian sites over last 5 years. Number of Georgian sites have been inspected by FDA without any major or critical findings, non of the sites or investigators have been black listed or suspended from the research. These are the list of the FDA inspections conducted in recent years. Data is generated from the FDA website.
- Relatively fast clinical trial approval process
- Physicians are very motivated to participate in clinical trials
- Sites are experienced in conduction of clinical trials
- Clinics are well equiped and facilitied – espacially in Oncology
- Data bases of patients with different pathologies exist in hospitals which can facilitate enrollment
- Visa-free travel to Georgia for visitors from the EU and USA (up to 90 days stay) facilitates site visits and audits
- Most patients are Treatment-Naive
- Some of our sites are already specified in JCI