Belarusian Approval Process

In Belarus clinical trials are conducted in compliance with the principles of the Declaration of Helsinki and the guidelines of the International Conference on Harmonization (ICH). Although Belarus is not a EU Member State, its legislation is harmonized with EU directives and GCP rules, the latter, implemented as a law in 1999.
Clinical study start-up time: 4.5 – 6 months

Belarusian Recruitment Potential

Patients are willing to participate in clinical trials to have access to novel therapies which are not yet available or not reimbursed by the Belarusian healthcare system.
Over the last two years, in Belarus about 180 studies were conducted mainly focusing on oncology, cardiology and diabetes.

Investigators and Sites

In Belarus are located over 600 public hospitals and 800 outpatient clinics, with over 80 accredited clinical study sites. Physicians practicing in the country are approximately 5.000; they usually speak very good English and are ICH GCP experienced which allows them to deliver very high recruitment and quality data. Belarus has very high hospital beds’ density: 112 beds/10,000 population.