Clinical research across Eastern Europe
Clinical Trials in Latvia
Local knowledge and operational support for sponsors conducting clinical research in an EU member state.
Discuss your study
Why conduct clinical research in Latvia?
- EU member state operating under the EU Clinical Trials Regulation and ICH-GCP.
- Experienced investigators and hospital-based research sites.
- Potential access to patient populations in cardiovascular, oncology and other therapeutic areas.
- Centralized EU submissions through the Clinical Trials Information System (CTIS).
Regulatory and ethics framework in Latvia
Latvia is an EU member state, so clinical trials of medicinal products are submitted through CTIS under Regulation (EU) No 536/2014. The national competent authority is the State Agency of Medicines (Zāļu valsts aģentūra), and ethics review involves the Central Medical Ethics Committee. Part I of the dossier is assessed jointly by the concerned member states, while Part II covers national aspects. Studies of medical devices and other non-medicinal products follow national procedures.
Typical start-up workstreams in Latvia
- 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 Latvia with neighbouring countries to reach enrolment targets.