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