Eastern Europe

Clinical trial services and Consulting in Eastern Europe.

Europe offers great opportunities for conducting high quality clinical research due to the existing centralized healthcare infrastructure, well-trained researchers and the generally high level of interest in the field of clinical research both the investigator and patient sides.

70% of clinical studies fail due to poor selection of clinical investigators and sites. Meditrial has an extensive database of sites and a broad network of clinical investigators in Europe and worldwide. Thanks to that, we can fulfil your clinical study requirements and recruit for you the most qualified clinical investigators and relevant sites for your research.

Moreover, we offer comprehensive clinical trial monitoring and site management services to support clinical trials around the world. We ensure that the study is conducted according to the protocol, GCP, SOP, and international regulatory requirements.

Our expertise covers all areas of Europe: Eastern, Central and Southern Europe. Meditrial can efficiently manage your studies thanks to our experts in local regulations and languages.

Why clinical trials in Eastern Europe?

  • Large databases of patients willing to participate in clinical studies
  • High enrollment rates
  • Well-educated and motivated Investigators
  • Highly qualified CRAs
  • Competitive prices in comparison to the USA, Western Europe or other regions

Belarus

– 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

– 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

Bulgaria

– 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

– 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.

Czech Republic

– Approval Process

Czech Republic has been a EU member since 2004 and its legislation has been almost fully harmonized with the EU including the Drug Law.
Clinical study start-up time: 4.5 months

– Recruitment Potential

Czech Republic is currently one of the most prevailing on the clinical trial markets thanks to its good compliance to ICH-GCP guidelines, and the presence of highly qualified clinical investigators. Czech Republic offers a good environment to perform clinical trials.

– Investigators and Sites

Czech Republic hosts more than 800 sites including public and private hospitals and clinics, fully equipped and offering the highest standard of treatment and diagnostic procedures. Investigators are ICH GCP experienced, well-educated with most of the Czech staff having scientific background, which leads to excellent relations with the investigators and high quality of data.

Georgia

– Approval Process

Georgia has relatively short timelines for study approval procedure.
Clinical study start-up time: 2.5 – 3 months (the shortest approval timeline in Europe)

– Recruitment Potential

Over 230 studies have been registered under the official clinical trial registry in Georgia (41% in cardiovascular diseases, 37 % in oncology, 12% in neurology and 10 % in other therapeutic areas). Patients are generally compliant and willing to participate in clinical trials due to limited access to novel therapies.

– Investigators and Sites

The majority of sites are located in the largest cities with Tbilisi, the capital, hosting the largest and most modern hospitals with expertise in all therapeutic areas. Sites and PIs specialized in cardiovascular diseases are considered the most experienced ones.

Lithuania

– Approval Process

Lithuania joined the EU in 2004 and since then harmonized the legislation on clinical trials with the EU, implemented Directives into the local regulations, and also started to follow the applicable EU guidelines.
Research start-up time: 3.5 – 4 months

– Recruitment Potential

Lithuania is a very attractive country for clinical trials because it offers access to a large group of patients who have not yet been treated with modern pharmaceuticals or devices (mainly due to economic limitations). Therefore, large patient groups are available in all major therapeutic areas.
Moreover, Lithuania offers a relatively short study start-up period, which makes it an excellent place to conduct “first-in-man” research.

– Investigators and Sites

There are approximately 145 sites in Lithuania, mainly public hospitals and outpatient clinics. Sites are properly equipped and procedures are conducted according to the European standard of care.
Investigators are ICH GCP experienced and well educated.

Poland

– Approval Process

Poland has been an EU member since 2004. The legislation almost fully correlates with the EU directives, including the Drug Law.
The realistic study start-up time is 5 months.

– Recruitment Potential

The population of Poland is 38 million.
Patients are willing to participate in clinical studies, which makes the recruitment rates much higher than in Western Europe or the USA.

– Investigators and Sites

For many years, Meditrial has helped sponsors to conduct clinical trials in Poland. There are over 1,200 sites (including more than 50 university hospitals and medical institutes). Public and private hospitals and clinics are well equipped and offer the highest standard of treatment and diagnostics. In addition, the presence of well-educated researchers providing high-quality data is one of the main factors that make Poland an attractive place to conduct clinical trials.

Ukraine

– Approval Process

Ukraine clinical trials legislation is completely harmonized with respective directives and guidelines of the European Union, despite the fact that Ukraine is not a member of the EU.
Clinical trial start-up time: 3 – 4 months

– Recruitment Potential

Recruitment of subjects in Ukraine is relatively fast and easy and recruitment rates are higher than those in EU countries or the USA. Due to the vertical referral system, investigators can recruit patients (mainly treatment-naïve) from the regional population without any competition inside.

– Investigators and Sites

Ukraine has a centralized health care system with a large number of public hospitals and clinics.
Investigators are ICH GCP experienced and very well trained which translates into high recruitment and good quality of collected data.

Slovakia

– Approval Process

Slovakia has been an EU member since 2004. The legislation almost fully correlates with the EU directives, including the Drug Law.
Study start-up time: 3.5 – 4 months

– Recruitment Potential

Slovakia offers an attractive environment to perform clinical trials. The population of the country is approximately 5.5 million.

– Investigators and Sites

There are approximately 300 sites in Slovakia offering the highest standard of treatment and diagnostic procedures. Public and private hospitals and clinics are well equipped. Investigators are ICH GCP experienced, very well educated, and motivated to deliver high-quality results.