A GLOBAL SERVICE PROVIDER OF PRECLINICAL AND CLINICAL RESEARCH IN OPHTHALMOLOGY
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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
- Literature review Phase I and phase II safety and dose finding trials
- Phase II exploratory efficacy trials
- Randomized controlled phase III trials
- Phase IV trials
- Pharmaco-epidemiology surveys
- Medico-marketing trials
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
