Regulatory and Ethics
Ethics Committees are either established at hospitals, the Chamber of Physicians or at the district government. One of the LECs is to be selected as "lead" EC providing a "single vote" for Slovakia; the others act as local ECs in charge of the trial site exclusively. The period for granting an EC's opinion is limited to 60 days. Additional and not in accordance with the EU CT Directive private sites have to be approved by the district government (samospravny kraj), after having obtained the national CA's and national EC's approval. The procedure may prolong the authorisation period beyond the 60-day timeline.

The parallel process of clinical trial authorisation by the competent Slovak authorities takes 60 days for phases I to IV; 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.
Since 2006 the applicant needn't to be a Slovak (natural or legal) person any more.

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

Customs clearance for IMPs of EU origin is not requested.

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.

Small country, highway access to major towns, highway to Czech Republic. No fast inter-city train system available. From Bratislava few direct flights to European capitals. Vienna (int’l airport) about 1,5 hour by car/ shuttle bus.
Local PHAMOS office
Business in Slovakia is run by the CEE headquarters in Prague and by the national study co-ordinator based in Bratislava. Slovak and Czech languages are almost identical so that communication with investigators, authorities, EC's and hospital depts. is easily possible for the Prague staff.

PHAMOS s.r.o., Letohradská 755/ 50, CR- 170 00 Prague 7, Czech Republic
Phone +420. 60 60 76 000
CRO services provided in Slovakia
Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, national project management 


Michael Frank, PhD
Poland Czech Republic Slovakia Hungary Romania Bulgaria