CRO in the Baltic States
The Baltic States offer a number of advantages for conducting clinical trials:
- Full compliance with ICH GCP (Good Clinical Practice) international standards.
- The study of the results of regulatory inspections, conducted by EU and US regulator representatives as well, shows a significantly lower percent of critical findings compared to other regions. From 1995 to 2017, 47% of clinical trials in the Baltic countries were fully approved by the FDA. The data were calculated on the basis of the ratio of NAI (No Action Indicated)1 to the number of conducted FDA inspections2.
- The researchers’ expertise, commitment and interest in clinical trials result in the high-quality data.
- A positive social image of clinical trials promotes quick patient enrollment into clinical trials.
- The clinical trial approval process is carried out in accordance with the EU requirements. The approval for the conduct of a clinical trial is issued within 60 weekdays.
- The decision on the issue (or on the denial of the issue) of the Certificate of Registration is made within 210 days after the application receipt. The Certificate of Registration remains in force for 5 years and can be extended for an indefinite period.
- The cost of the state registration of medicinal products is significantly lower than in other EU countries.
- A large number of big clinical research centers allow them to conduct clinical trials at the highest level.
1Read more about classification of violations here.
2Read more about the number of inspections performed by the FDA here.