Bioequivalence Studies

Bioequivalence Studies in the Republic of Belarus are conducted in accredited Centers and Testing Laboratories. Our company delivers services concerning the preparation of all required study documents and their approval by regulatory authorities and study centers. We supervise the study conduct at all stages.

OUR SERVICES INCLUDE:

• Search and selection of study centers

• Elaboration of all required documentation of study, including Study Protocol, Informed consent form, Case Report Form, Investigator's Brochure, sampling charts etc.

• Coordination of programs in centers and laboratories

• Securing of the study approval by the Ministry of Health of the Republic of Belarus

• Securing of the study approval by local Ethics Committees

• Conclusion of agreements with study centers

• Monitoring of every stage of study

• Statistical processing

• Preparation of final report

ALPHALEK ensures a prompt elaboration of all documents, receipt of required adoptions and approvals as well as a strict control over the study conduct.