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Medical writing

With 19 years of experience in clinical research in ophthalmology, Iris Pharma has substantial knowledge of and experience in writing study designs, clinical trial protocols, and clinical trial reports in accordance with ICH guidelines.

 

STUDY DESIGN

 

PROTOCOL DEVELOPMENT AND STUDY DOCUMENTS

  • Protocol writing according to ICH guidelines
  • Patient information sheets & informed consent
  • Case report forms
  • Patient diaries

 

MEDICAL REPORTS

  • Clinical study reports according to ICH guidelinesthat integrate:
    • Complete documentation of the study design and method
    • Reporting of results with statistical evaluation
    • Tables and graphs of main results
    • Discussion and conclusion
  • Investigator's brochure writing
  • Publications