Approval Process
The Czech Republic was established on 1st January 1993 as the Western part of former Czechoslovakia. It is a EU member since 2004. The legislation has been almost fully harmonized with EU including the Drug Law.
- realistic start-up time: 4.5 months
Recruitment Potential
Among European countries, the Czech Republic is currently one of the most dominant clinical trial markets. With a population of approximately 10.5 million, reportedly good compliance to ICH-GCP guidelines, and the presence of highly qualified clinical investigators, the Czech Republic offers a good environment to perform clinical trials.
The Czech Republic has the third highest colorectal cancer incidence rate in the world and one the highest renal and pancreatic cancer incidence in the EU.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Czech Rep. | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 506.3 | 240.9 | 465.2 |
| Neoplasms | 272.2 | 222.1 | 236.2 |
| Digestive diseases | 44.7 | 32.0 | 30.9 |
| Respiratory Infections | 34.3 | 43.6 | 28.9 |
| Mental and substance use disorders | 4.8 | 4.3 | 11.1 |
Data from World Health Organization
Investigators and Sites
There are over 800 sites in the Czech Republic, both public and private hospitals and clinics, fully equipped and offering the highest standard of treatment and diagnostic procedures. Site density is the highest one in European region and accounts for 77 (number of sites per 1 million population).
Investigators are ICH GCP experienced, well educated, motivated and deliver very high quality data.
Most of the Czech staff have scientific background, which leads to excellent relations with the investigators and high quality of data.