Population of CEE Countries

The total population of the countries in which Argint can conduct clinical trials approaches 100 million with the largest countries, in terms of population, being Romania (23 million), Czech Republic (10.2 million), Hungary (10 million) and Serbia (9.4 million).

Regulatory Environment

Most of the CEE countries have either adopted the European Clinical Trials Directive (EU member countries and Romania) or are in the process of bringing their regulatory system in line with the directive in preparation for future EU membership.

EU Member Countries: Austria, Bulgaria, Czech Republic, Hungary, Romania, Slovakia, Slovenia

Non-EU Countries: Bosnia, Macedonia, Montenegro, Moldova, Serbia

It takes between 2 and 4 months to obtain regulatory and EC approval in most CEE countries.

Quality
Overall the quality of work delivered by investigational sites in CEE compares favorably with sites in Western countries.  In our experience the site staff make great efforts to ensure the studies are run according to the protocol and in line with local regulations and ICHGCP.  Guidance provided by CROs and sponsors is accepted and there is a refreshing willingness to learn and improve practice. 

Argint sites have been inspected by the Hungarian and Serbian Agencies with favorable outcomes.