Planning Clinical Trials Outside the EU: Georgia and Ukraine

Georgia and Ukraine are not part of the EU Clinical Trials Regulation system, so studies there follow national procedures. That changes the way sponsors plan timing and logistics.

National submissions and ethics review

Each country has its own regulatory authority and ethics review process, with its own forms, languages and expected documents.
Confirm the current requirements for your protocol at the start of feasibility, because procedures and timelines can change.
Plan translations and local formal requirements in parallel with the global dossier.

Investigational product logistics

Import permissions, customs clearance, labelling and storage conditions must be arranged before sites are activated.
Agree the supply chain and contingency stock with your depot and local partners.

Planning for risk in Ukraine

Current conditions can affect site operations, travel and patient access, so risk planning should be part of the study design.
Define backup sites, communication routes and criteria for pausing or moving activities.
Prioritise patient safety and data integrity in every decision, and review the plan regularly.

Combining with EU countries

Many sponsors run Georgia or Ukraine alongside EU countries such as Latvia, Lithuania and Poland to reach enrolment targets. Plan the regulatory timelines of both groups together.

Discuss your study

Share your protocol synopsis and target countries, and we will respond with a feasibility view.

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