Georgia’s Rising Status as a European Clinical Trials Destination
With the on-going conflict in Ukraine, some clinical trial sponsors are turning their attention to other European countries to conduct their research. Georgia is rapidly emerging as a key alternative providing excellent potential for the biotechnology and pharmaceutical industries.
In recent times there has been significant investment in the country’s health system with the creation of several new facilities and programmes in addition to an increase in the number of experienced physicians.
In this article we explore the untapped benefits of Georgia as an emerging destination for multinational clinical trials in Europe.
Fast Start-up Timelines
Whilst neighbouring countries experience lengthy waits for clinical trial application reviews, in some cases up to six months, this can be awarded in a shorter two-month timeline from submission to the start of studies. A further advantage is that there is no need to obtain import licenses for IMP. Additional approval is needed for comparators and medical test systems such as urine or pregnancy tests, no need for lab kits and biosamples.
Georgia benefits from a population of almost 4 million, offering timely patient recruitment opportunities.
With therapeutic areas across oncology, the central nervous system, infectious disease, gastrointestinal disease, and immunology, Georgia is already well established as an excellent location for clinical trials.
Since 2020 there have been over 100 clinical trials in Georgia. The bulk of these came from international sponsors with a strong focus on managing Phase II-III multinational trials.
With a growing potential, the country boasts 172 registered investigational sites, with 16 of these managing 20 clinical trials. An added benefit is that most Eastern European CROs already have experience in clinical studies in the territory in addition to registered offices within Georgia.
Other benefits of conducting clinical trials in Georgia include:
- Full compliance with Good Clinical Practice (GCP) guidelines.
- Clear regulatory requirements including Good Distribution Practice (GDP) and simplified process of document submission.
- Highly qualified and motivated medical investigators providing high quality data inspected and approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
- Availability of site teams and patients.
- Proven track record with internationally recognised standards for disease treatment and prevention.
Leading the Way with Clinical Trials Services in Europe
Oximio has been providing clinical trials services within Georgia since 2017. From its dedicated GDP/ISO certified depot in Tbilisi, along with a courier fleet, it can provide a quick distribution service including direct to patient deliveries.
A key requirement for many sponsors is temperature control, particularly when it comes to biological samples. Leading the way, Oximio provides dedicated support for the storage and distribution of investigational medicinal products and clinical trial materials. Coupled with regulatory and customs experience, sponsors can access quick customs clearance and are assured of shipment integrity at all times.
A second depot in Georgia, which is located in a Free Trade Zone, enables supply, storage and distribution to multiple Caucasus countries from a regional depot. Oximio are well placed to provide unique access to patient populations in Eastern Europe via their GxP-compliant depot network covering Georgia, Hungary, Turkey, Israel, Serbia and Ukraine.
Full details of Oximio’s clinical trials services can be found on the website:
- Clinical Trials Logistics
- Sourcing for Clinical Trials
- Patient Focused Services
- Adaptive Logistics for Advanced Therapy
Clinical Trials Services in Georgia
To find out how we can help you with your clinical trials in Georgia and Eastern Europe, simply contact us today. We’d be delighted to discuss your requirements and assist you with your research.
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The VAT and customs implications of clinical trials are often overlooked, with focus largely taken up by product sourcing requirements, temperature control, local regulations, and DCT setup. But taking a tactical approach can significantly reduce VAT and customs challenges, making the budget stretch further. This paper from Oximio addresses the key considerations for VAT across Europe in the supply chain, as well as five cost optimisation takeaways.