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Development of clinical study documents

Development of clinical study documents

Vita Aeterna company develops a full package of documents for all types of clinical studies. Our aim is to provide an optimum solution for the conduct of clinical studies for further registration of a study drug.


  • Development of a study design;

  • Calculations and confirmations of sample size;

  • Development of clinical study documents: protocol, informed consent, investigator’s brochure, paper and electronic CRF, patient’s diary (if necessary);

  • Statistical analysis plan;

  • Final statistical and clinical study report;