When a UK sponsor adds Georgian sites to a multinational study, most of the early attention goes to the regulator, the ethics committees and the investigators. The supply side gets less of it, yet that is often where the timeline slips. Investigational medicinal products (IMPs) have to cross a border, wait in licensed storage and reach hospital pharmacies at the right temperature. In many protocols, biological samples then have to travel back to a laboratory in Britain or elsewhere in Europe. Each of these steps follows its own rules in Georgia, and each is easier to arrange before the first patient is screened than after.
Why the country makes the shortlist
Georgia, in the South Caucasus, has hosted international clinical research for many years. Sponsors who choose it tend to point to investigators familiar with multinational protocols, steady recruitment in several therapy areas and short distances between the main hospitals.
None of that helps if the product is held up at the airport.
The border comes first
Georgia sits outside both the UK and the EU customs areas, so every shipment of trial supplies is an export on one side and an import on the other. The first question is legal rather than logistical: who is the importer? In Georgian practice this is usually the authorised contract research organisation (CRO), and a licensed customs team clears the goods on its behalf under a power of attorney.
That arrangement should be settled before the first shipment is booked, together with the declared values, the temperature conditions on the shipping documents and any tax exemptions available for trial supplies. Permission to import trial supplies follows from the study’s regulatory approval, so the paperwork can be prepared well ahead. A consignment that lands with an incomplete file waits at the airport while its temperature budget runs down.
Storage that will pass an audit
Good Distribution Practice (GDP) became compulsory in Georgia in 2022, and any depot holding IMPs now needs a local GDP certificate. UK and European sponsors usually look for more: evidence that the depot also works to the EU GDP Guidelines, a certified quality system and temperature mapping for every zone their product will use. The certificates are worth reading in full, including the issuing body and the expiry date.
Deliveries out, samples back
From the depot, product goes to hospital pharmacies at the study sites. Each delivery should arrive with a temperature record the pharmacist can check on receipt. The sponsor should also know in advance what happens when a reading falls outside the range: who quarantines the stock, who tells the study team and how quickly a replacement can be sent.
Samples move in the opposite direction. Blood or tissue collected at a Georgian site may need to reach a central laboratory in the UK or the EU within a fixed number of hours, chilled or frozen, with dangerous goods paperwork prepared to IATA rules. Visit schedules and flight schedules have to fit together. A sample drawn late on a Friday is a familiar weak point, because the depot, the courier and the receiving laboratory all have to be ready for it.
Questions for a local partner
A short set of questions shows how a depot works in practice. In what capacity does it sign customs documents? Which labelling work does its licence allow, and which does it exclude? What will the sponsor actually receive during the study: inventory reports, shipment confirmations, excursion reports, and how often? How are returns reconciled at close-out, and who signs the destruction record? A partner that answers these in writing before the contract is signed is likely to answer them just as clearly during an audit.
A local example
GeoStorage, founded in Tbilisi in 2010 as Georgia’s first specialised clinical trial depot, is one company that covers this chain. It has been certified by SGS against the EU GDP Guidelines since 2018, holds a GDP certificate from the Georgian competent authority and has worked under ISO 9001 since 2014. By the company’s count, its storage and distribution work has covered more than 150 clinical trials.
Its customs team handles customs clearance for clinical trials on behalf of the authorised CRO, which remains the importer, under a power of attorney. The team prepares the import documentation and pays the taxes on the client’s behalf, and with complete documents, clearance typically takes 24 to 48 hours. Inside the depot, labelling is limited to placing approved additional labels on existing packaging, on written instructions. Deliveries to sites travel with calibrated temperature loggers, and clients are kept informed through inventory reports and shipment confirmations. In the other direction, GeoStorage picks up biological samples from sites, stores and packs them, and arranges their export to laboratories abroad.
Plan the supply route with the sites
Georgia can shorten a study’s start-up, but only when the supply plan is ready as early as the regulatory file. For a UK sponsor, that means choosing the importer, the depot and the sample route at the same time as the sites.
