Clinical trials of II-III phases

Our company has a wide experience in the field of organization and conducting of clinical trials of late phases (II-III).

Long-term cooperation with experienced clinical centers in Russia and abroad allows us to organize and conduct such trials on all possible ICD codes. In these clinical centers there is a whole base of patients structured according to the diseases, which allows to promptly and qualitatively choose the required number of compliant patients.

Our business scope includes the following activities:

• trial planning, selection of a clinical entity
• calculation of sampling size, trial design, comparison with patient management standards
• literature data analysis, preparation of the investigator's brochure, review of literature on preclinical and clinical trials according to the CTD format,
• selection of the clinical center, training of personnel, project management, monitoring
• logistics services for the delivery of trial materials and study drugs to clinical centers
• selection and supervision of the central laboratory (if necessary)
• statistical processing of the results obtained using modern software
• preparation of the final report on the clinical trial in accordance with local requirements, as well as in the concept with the recommendations of the EU and the EEU