Approval Process
Slovakia was established on 1st January 1993 as the Eastern 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: 3.5 – 4 months
Recruitment Potential
With a population of approximately 5.5 million and the presence of highly qualified clinical investigators, Slovakia offers a good environment to perform clinical trials.
Slovakia is one of the EU leaders with regards to colorectal, uterine and pancreatic cancer incidence rate.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Slovakia | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 523.4 | 240.9 | 465.2 |
| Neoplasms | 225.6 | 222.1 | 236.2 |
| Digestive Diseases | 53.6 | 32.0 | 30.9 |
| Respiratory Infections | 40.7 | 43.6 | 28.9 |
Data from World Health Organization
Investigators and Sites
There are approximately 300 sites in Slovakia, both public and private hospitals and clinics, aproprietly equipped and offering the highest standard of treatment and diagnostic procedures. Investigators are ICH GCP experienced, well educated, motivated and deliver very high quality data.
All of the Slovak CRAs are physicians, which leads to excellent relations with the investigators and high quality of data.