Clinical research across Eastern Europe
Clinical Trials in Poland
Operational and regulatory support for clinical research in one of Central Europe’s largest patient markets.
Discuss your study
Why conduct clinical research in Poland?
- Large and diverse patient population across major urban and regional centers.
- EU member state operating under the Clinical Trials Regulation and ICH-GCP.
- Experienced investigators, hospitals and research teams.
- Clinical trial applications coordinated through CTIS, with national oversight by the relevant Polish authorities.
Regulatory and ethics framework in Poland
Poland is an EU member state, so clinical trials of medicinal products are submitted through CTIS under Regulation (EU) No 536/2014. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) and the national ethics review bodies are involved. Roles and procedures have evolved since the Regulation applies, so we confirm the current route for each protocol.
Typical start-up workstreams in Poland
- 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 Poland with neighbouring countries to reach enrolment targets.