CLINICAL TRIALS IN POLAND
Regulatory and Ethics
For multi-centre studies the sponsor must designate a Coordinating Investigator who will submit the application to his/her local Ethics Committee (EC). The EC of the Coordinating Investigator will act as national EC and will grant a "single vote" for Poland conc. the clinical trial protocol and related documents as well as conc. the trial supervision by the coordinating investigator. It also will request the opinion of the local ECs in charge conc. the suitability of the other trial sites/ investigators.

The clinical trial has to be notified to the "Office for Registration of Medicinal Products, Medical Devices and Biocidal Products" which will grant or refuse an authorisation within 60 days. Any objections or request for more information may prolong the approval process.

The insurance for patients and investigators must be concluded with an insurance company based in Poland, or with an international insurance running a Polish affiliate office. Terms of the insurance must be available in Polish.

Overall approval time is 60 days for all phases but collection of documents requested by authorities and EC as financial contracts, signed protocols and permits of hospital directors for conducting the trial may prolong the preparation of submission. 
Health care system
The degree of privatisation in the medical sector is lower than e.g. in the Czech Republic and may range up to 30 %. Therefore, a major part of outpatients could be recruited in the respective hospitals’ departments.
Infrastructure
Communication facilities comparable to Western Europe.

Large country, nearly no highways between major towns, fast inter-city train system available exclusively on the axis Berlin- Warsaw and from Warsaw to few major cities, national flights rare and expensive.
Local partner CRO
CLINMARK Clinical Research, KEN 88/102 Street, Warsaw, Poland
Phone: +48. 22 716 55 30  Mobile +48. 502 778842  Fax: +48. 22 716 5533
Email: poland@phamos.cz 
Web site: www.clinmark.pl
CRO services provided in Poland
Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, national project management
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