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Phase study II

Phase study II

First controlled studies in a small number of patients to establish a therapeutic drug effect. During the studies, drug safety and tolerability is established, drug efficacy, effective dosage are determined, and frequency of administration is selected.


  • Development of protocols of phase II studies;

  • Development of supporting documents (protocol, investigator’s brochure, patient informed consent, paper and electronic CRF);

  • Selection of clinical bases for phase II studies;

  • Insurance of patients participating in phase II studies;

  • Obtaining approvals for a phase II study;

  • Arrangement, monitoring, data management and statistical processing of results of II phase studies;

  • Preparation of the final report on phase II studies;