Georgia is a rapidly developing country with a unique location at the crossroads of Eastern Europe and Western Asia and a population of 3.71 million. COREX Logistics has been working in Georgia since 2016 — one of our state-of-the-art warehouses is located in the capital Tbilisi. We are pleased to share our insights about Georgia’s untapped potential as a location for international clinical trials.
A country with a pro-business climate and robust healthcare system, Georgia boasts significant advantages for sponsors seeking to carry out both novel and rescue studies. Here’s what makes Georgia a great spot for international clinical trials:
1. Positive economic and socio-demographic environment
Several economic reforms introduced in recent years have contributed to Georgia’s reputation as an emerging location for international companies conducting clinical trials. A total of 47 clinical trials were conducted in Georgia between January, 2019, and January, 2020. All of these trials were initiated by international sponsors and had a diverse range of therapeutic indications:
Georgia’s clinical professionals are in general positively inclined to participate in clinical trials. The country’s ethnically diverse population is also well-disposed to participating in trials while also being largely treatment-naïve in a wide range of clinical areas. Overall, accessible patient populations and high recruitment rates make Georgia a hidden gem for sponsors seeking rapid patient recruitment.
2. Rapidly evolving healthcare system
A robust healthcare system is a crucial factor when choosing a suitable country to conduct clinical trials. Over the course of the last 20 years, Georgia has undergone several rounds of a healthcare reform. The country’s healthcare system has been therefore significantly modernized, resulting in increased quality and efficiency of health services, medical equipment, and clinical facilities.
Georgia also possesses a large skilled and motivated medical staff, full compliance with ICH-GCP standards and a large number of medical institutions with experience in clinical trials.
3. Ultra fast (less than 2 months) start-up timelines and rapid regulatory process
You can’t go from regulatory submission to study initiation in less than 2 months in most countries. Georgia is a notable exception in that respect:
- The review of study submission by local Ethics Committees takes 2 weeks on the average;
- The subsequent approval of the submission by the regulatory authority (State Regulation Agency for Medical Activities) usually takes no longer than 3 weeks;
- Negotiation and signature process takes around 2 weeks and may be done in parallel with the study approval process;
- The whole journey from submission till first site initiation takes 56 days on the average;
- The import-export licences for study drugs, lab kits and bio-samples are not required in Georgia.
As can be seen from the above, the relatively smooth regulatory process in this country facilitates speedy timelines from submission to start-up of clinical trials. This is just one of the factors making Georgia a very attractive prospect for sponsors and pharma from all around the world.