Clinical Trials

Clinical Trials in the territory of the Republic of Belarus are conducted in full concordance with GCP requirements. ALPHALEK provides the full suite of services, from the elaboration of protocol to the preparation of final report, and ensures that clinical trials are conducted at a scheduled time

ALPHALEK team participated in the organization of more than twenty international and local clinical trials and bioequivalence studies conducted in the territory of the Republic of Belarus.

OUR SERVICES INCLUDE:

• Search and selection of study centers
• Elaboration of study documentation (Study Protocol, Informed consent form (ICF), Case Report Form (CRF), Investigator's Brochure (IB), patient diaries etc.)
• 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
• Importation of investigational products and study materials
• Exportation of biological samples
• Study monitoring
• Statistical processing
• Preparation of final report

ALPHALEK ensures a structured comprehensive approach to all stages of a clinical trial according to GCP standards, regulatory requirements and standard operation procedures of the company.