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, Czech Republic, Hungary, Slovakia, Slovenia
EU Accession Countries (expected to join EU in Jan 2007): Bulgaria, Romania

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. 

Regulatory inspections of CEE sites, including inspections by the FDA, have produced favorable results.