Phase III study
Multicenter studies in various populations of patients are carried out to prove drug efficacy and safety.
Development of phase III study protocols;
Development of supporting documents (protocol, investigator’s brochure, patient informed consent, paper and electronic CRF);
Selection of clinical bases for phase III studies;
Insurance of patients participating in phase III studies;
Obtaining approvals for a phase III study;
Arrangement, monitoring, data management and statistical processing of results of III phase studies;
Preparation of the final report on phase III studies;