Bulgarian Approval Process

Bulgaria joined the EU in January 2007; as such, the regulation regarding clinical trials complies with EU guidelines.
Clinical study start-up time: 4 – 4.5 months

Bulgarian Recruitment Potential

The major specialized clinics and university hospitals are located in Sofia. Patients are motivated to participate in clinical trials, therefore large groups of subjects are available across different therapeutics areas.

Investigators and Sites

Bulgaria hosts around 100 sites, 20 of which are located in Sofia. Investigators are ICH GCP experienced and qualified by education, training and experience. Moreover, most of the Bulgarian CRAs are physicians, pharmacists, biologists or nurses, which leads to excellent relations with the investigators and excellent quality of the data.