Reasons why Georgia needs to be on your list of locations for clinical trials
Reasons why Georgia needs to be on your list of locations for clinical trials
With its rapid regulatory approval process, significant naïve populations in a range of therapeutic areas, skilled medical personnel and a conducive economic environment for doing business, Georgia is regarded as a hidden gem for those interested in initiating novel studies and rescue trials.
Cromos Pharma in Georgia
Cromos Pharma began managing clinical research in Georgia in 2013. Since then, our Tbilisi-based operation has grown exponentially, managing numerous successful regional and global studies in a broad range of therapeutic areas.
Advantages
Lightning fast approval process. Georgia’s regulatory approval process takes on average about two months.
Georgia’s rapidly growing study-related workforce is well experienced in international, ICH GCP-compliant clinical trials.
Georgia’s investment in the healthcare sector over the last decade has increased the number of medical facilities and in-patient beds.
Most hospitals are well-equipped, and the staff is eager to participate in clinical research.
Good recruitment potential due to an ethnically diverse population with treatment- naive patients in a range of therapeutic areas.
Georgia’s costs of clinical research are much lower than the US or Western Europe.
Economic and political reforms have made Georgia an attractive and welcoming destination for international companies seeking to do business there.
Investigators and their patients are highly motivated to participate in trials as a way of accessing novel therapies not yet available through the national health system.
Snapshot of clinical trials
According to clinicaltrials.gov a total of 40 clinical trials were initiated in Georgia between Jan, 1st, 2020 and Jan, 1st, 2021. The majority initiated by international sponsors (incl. 22 US) and were Phase II and III.
By Therapeutic Area:
Fourteen different therapeutic areas including: Heart Disease, brain diseases, central nervous system diseases, neurological diseases, RNA infections and other viruses.
Rapid Approval Process
Georgia boasts an impressively rapid regulatory study approval process (<2 months from submission to study start). This rapid startup timeline, combined with a pool of skilled and professional medical staff, full compliance with ICH GCP standards and a solid reputation for producing high quality results make Georgia a very attractive prospect for sponsors.
Key features of regulatory approval
Short start-up timelines.
Approval by local Ethics Committees (local ECs) precedes approval by the Regulatory Authority (RA = LEPL Regulation Agency for Medical and Pharmaceutical Activities at Ministry of Internally Displaced Persons from the Occupied Territories, Labor, Health and Social Affairs of Georgia).
No import-export license is needed for study drug or for lab kits / bio samples.
Insurance for clinical trial should be obtained from local insurer.
