Clinical research across Eastern Europe
Clinical Trials in Lithuania
Local operational support for clinical research under the EU Clinical Trials Regulation and ICH-GCP.
Discuss your study
Why conduct clinical research in Lithuania?
- EU member state operating under the Clinical Trials Regulation and ICH-GCP.
- Established healthcare institutions and experienced study teams.
- Access to Baltic patient populations across multiple therapeutic areas.
- EU submissions coordinated through CTIS.
Regulatory and ethics framework in Lithuania
Lithuania is an EU member state, so clinical trials of medicinal products are submitted through CTIS under Regulation (EU) No 536/2014. The State Medicines Control Agency (Valstybinė vaistų kontrolės tarnyba) and the Lithuanian Bioethics Committee are the main national bodies involved. Studies of medical devices and other non-medicinal products follow national procedures.
Typical start-up workstreams in Lithuania
- Country feasibility: review of the protocol against local standard of care, investigator interest and patient availability.
- Regulatory and ethics submissions: preparation, translation and tracking of submission packages and responses to authority questions.
- Contracts and budgets: site agreements, budget negotiation and insurance documentation.
- Site activation: qualification, training, essential documents and investigational product logistics.
- Conduct and oversight: monitoring, issue escalation and sponsor reporting through close-out.
Timelines, authority requirements and site capacity change over time, so we confirm current conditions for your protocol during feasibility rather than quoting generic figures.
Multi-country studies
Many sponsors combine Lithuania with neighbouring countries to reach enrolment targets.