Bioequivalence studies

InfoLex organizes and performs bioequivalence studies of generics, provides full complex of studies.

Experienced specialists of our company will efficiently perform the following work:

• development of bioequivalence study protocol;
• presentation of support documents: CRF, patient information sheet; informed consent form, investigator’s brochure;
• preparation of report and statistical analysis;
• choice of clinical base for studies;
• organization of insurance of volunteers participating in the studies;
• organization of auditory and monitoring visits to clinical bases;
• submission of documents to the MOH of the RF;
• receipt of approval from the MOH of the RF.