Clinical Trials in Georgia

Country Overview

Why Georgia for Clinical Trials?

Georgia has established itself as one of the fastest-growing clinical research destinations in the world. With more than 800 international studies registered on ClinicalTrials.gov, the country offers a proven track record of high-quality data, rapid patient enrollment and smooth regulatory processes — all at a fraction of the cost of Western European sites.

aCROss Medical operates a network of experienced investigative sites across Tbilisi and regional cities, covering a broad range of therapeutic areas from cardiology and neurology to orthopaedics, urology and ophthalmology. Our team has deep local relationships with principal investigators and ethics committees, ensuring that your study starts fast and runs efficiently.

Key Advantages

• Ultra-fast start-up: first site initiated within 2–3 months of regulatory submission
• Full ICH-GCP compliance — data accepted by US FDA and EMA
• Large treatment-naive patient pool with strong enrollment rates
• Highly motivated, internationally trained medical staff
• Streamlined national regulatory agency (MEPA) and EC review process
• Cost-effective operations — significantly lower than Western Europe or the US
• No language barriers — sponsor teams work in English throughout
• Direct flights to major European hubs from Tbilisi International Airport

Regulatory Environment

Georgia's regulatory framework for clinical trials is governed by the Medicines and Pharmacy Regulation Agency (MEPA). The authority has streamlined its review process to support international sponsors, with typical approval timelines of 6–8 weeks for the regulatory submission and 4–6 weeks for ethics committee review — among the fastest in the region.

Georgia has harmonised its clinical trial legislation with ICH E6(R2) Good Clinical Practice guidelines, ensuring that data generated at Georgian sites is accepted by major regulatory agencies worldwide, including the US FDA and the European Medicines Agency.

Therapeutic Expertise

Our Georgian sites have proven experience across multiple therapeutic areas, including cardiology, neurology, orthopaedics, urology, oncology, endocrinology, pulmonology and ophthalmology. aCROss Medical's dedicated ophthalmology unit — aCROss Vision — is based in Tbilisi and operates as a Centre of Excellence for ocular clinical trials.

Our Local Team

aCROss Medical was founded by physicians who have worked as sponsors themselves. Our Georgian team includes experienced Clinical Research Associates, regulatory affairs specialists, data managers and project managers — all based locally and available to support your study from submission to final report.