Clinical studies – a process of stage-wise studies on a drug safety and efficacy (BAA, medical device). Drug clinical studies are divided in several phases:
1) I phase – first in-human drug safety and tolerability is examined in the phase; adverse reactions are newly identified;
2) II phase – efficacy and safety in a certain disease is examined.
3) III phase — examined on large groups of subjects, efficacy and benefit/risk in several diseases are examined.
4) IV phase – post-authorization (postmarketing) clinical studies, determination of new indications of study product in comparison with the same group of drugs.
Prior drug clinical studies, you should carry out several preclinical studies on a study drug (specialists of our company will help you to carry out most optimum and economic preclinical studies on drugs, BAA, medical devices), see more details in section Preclinical studies).
Clinical studies of a medical device (medical equipment) are carried out somewhat in a simpler way in comparison with drugs as they are carried out directly in humans strictly in accordance with an instruction for medical use of one or another product.
Clinical studies of BAA are carried out to examine efficacy and therapeutic properties of a future product to facilitate a marketing promotion.
Study execution terms: 1-12 months depending on a study extent and aim.
As well, specialists of our company provide services on clinical examinations with the use of such diagnostic equipment as computerized tomography, MRI apparatus and ultrasonic diagnostics apparatus. Medical centers in which examinations may be made with the use of magnetic resonance tomography, computerized tomography and ultrasonic diagnostics are located in such cities as: Kiev, Khmelnitsky, Rovno. See more details in section Examinations with the use of CT, MRI, USD.