Regulatory and Ethics
The process of clinical trial authorisation by the competent Czech authorities takes up to 60 days for all trial phases; EMEA's request form is to be used. Any objections or requests for completion may prolong the authorisation process. The extent of documentation to be submitted, esp. pharmaceutical data (IMP dossier) depends on the trial drug's registration status in the EU and complies with the requests of the EU Directive.

Customs clearance for IMPs of EU origin is not requested.

Conc. approval by ECs the EU Directive has been fully implemented: Study has to be submitted to one Multi-centric EC, approval period limited to 45 days. Study sites have to be approved by Local ECs in charge after having obtained the favourable opinion of the MEC, taking another 15 days. Local EC mustn't comment the project once approved by the MEC but may disagree with the site's participation. MEC's and LEC's opinions can be applied for in parallel to the submission to the CA and will be independently granted.

Standard patient insurance fully acknowledged but insurance must have a national representative, insurance for investigators and sponsor required.

Overall approval time for both in parallel, EC and CA, is about 60 days.
Health care system
Depending on specialisation, the degree of privatisation ranges from 20% to 80% and a major part of outpatients could still be found centrally in hospitals.
Communication facilities comparable to Western Europe (cell phone net, high speed internet)

The highway cuts the country diagonally and provides a fast access to all major towns, no fast inter-city train system available, distances too short for national flights.
PHAMOS Central & Eastern Europe s.r.o.,
Letohradská 755/ 50, CR- 170 00 Prague 7, Czech Republic
phone +420. 60 60 76 00


CRO services provided in Czechia
Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, (medical) project management, medical consulting esp. in Gynaecology, Ophthalmology, Psychiatry, Geriatry, Central Lab services medically supervised


Michael Frank, PhD
Poland Czech Republic Slovakia Hungary Romania Bulgaria