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Georgia is a hidden gem for those interested in rapid initiation of clinical trials.

Georgia offers international sponsors significant benefits that include a rapid regulatory approval process, substantial naïve patient populations in a wide range of therapeutic indications, skilled medical personnel, and a conducive economic environment for doing business. Cromos Pharma began conducting 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 indications.

Georgia Quick Facts
7.1
physicians
(2019)
per 1 000 population
2.9
hospital beds
(2014)
per 1 000 population
3.2
millions
(2023)
Total population
36
initiated clinical trials
in 2022
74.2
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in Georgia:
  • 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 past decade has increased the number of medical facilities and in-patient beds
  • Most urban hospitals are well-equipped with clinical staff eager to participate in clinical research
  • The cost of conducting clinical research is much lower when compared to the US and Western Europe
  • Excellent recruitment potential that stems from an ethnically diverse population of treatment-naïve patients in a broad range of therapeutic indications
  • Investigators and their patients are highly motivated to participate in trials as a way of accessing novel therapies not yet available through the national healthcare system
  • Economic and political reforms have made Georgia an attractive and welcoming destination for international companies seeking to do international business

Cromos Pharma’s Services in Georgia:

What we do

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Patient recruitment
Patient recruitment
  • Promotional and educational materials
  • DTC outreach
  • Investigator’s materials
  • Booster visits
  • Referral sites
  • Commitment to patients
  • Patient’s materials
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Clinical Research Services
Clinical Research Services
  • Capability and Feasibility Assessment
  • Project Management
  • Monitoring Services
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Regulatory
Services
Regulatory Services
  • Compilation of initial documents for RA and ECs/IRBs
  • Review of IC documentation
  • Obtaining of trial subjects’ insurance
  • Secure import/export licenses
  • Regional regulatory consultation
  • Regulatory strategy and clinical development planning
  • Submissions to Regulatory Agencies
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Medical
Writing
Medical Writing
  • Study concepts and outlines
  • Clinical study protocols and amendments
  • SAP for inclusion into protocol
  • Investigator Brochures
  • Investigational Medicinal Product Dossiers
  • Patient Informed Consent Forms
  • Clinical Study Reports
  • Executive summaries for efficacy or safety, ISS, ISE
  • Reviews of clinical and nonclinical data
  • Patient narratives, SAE narratives
  • Abstracts, posters, and journal articles
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Biostatistics
and data
management
Data Management
  • CRF development/validation
  • Customized database design/validation
  • Data entry screen design/validation
  • Double data entry
  • Programming under SAS
  • Data validation
  • Data listings
  • Convenient data format for the client
  • Data transfers
  • Data coding
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CTM
Logitics
CTM Logitics
  • Full Scope of Clinical Trial Logistics Services
  • Controlled access to storage areas
  • 24/7 receipt of IMP and CTM
  • Patented warehouse database program
  • General liability and property insurances
  • Compliance with ISO 9001:2015 & GDP
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PV
Support
PV Support
  • Therapeutic, technical, and operational excellence
  • Tailored and cost-effective safety solutions
  • Flexible outsourcing of safety functions
  • A team of QPPVs for registered products in EU
  • Updated country-specific regulatory requirements
  • Robust quality system
  • Pharmacovigilance consultancy
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Independent
Audits
Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check
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Rare and
Orphan
Diseases
Rare and Orphan Diseases
  • Circumventing recruitment challenges
  • Integrated expertise and support – what does this mean?
  • Active engagement with disease-specific societies and support groups
  • Effective use of referral sites

Georgia

Tbilisi office

Office 409, 4th floor 19 Davit Gamrekeli str. 0160 Tbilisi Georgia

Tel: +995 32 247 3806

Georgia Country Profile

Сlinical trials in Georgia – Country Profile 2022
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. Georgia is regarded as a hidden gem for those interested in initiating novel studies and rescue clinical trials...
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