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Phase IV study

Phase IV study

Studies of drug products are carried out after drug registration. The studies are carried out for: expansion of the therapeutic profile of drugs, obtaining additional efficacy information (various dosage forms, doses, treatment regimes and duration, drug interactions, new groups of patients), identification and characteristics of previously known adverse reactions and risk factors.

Services:

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

  • Selection of clinical bases for IV phase studies;

  • Arrangement, monitoring, data management and statistical processing of IV phase study results;

  • Preparation of a final report for IV phase studies;

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