 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 (CT1 rev2
sect. J)
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.
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.
Infrastructure
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.
Headquarters
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
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