Consulting & communication ►

Consulting & communication ▼

▪ Strategic and global drug developm(...)

▪ Communication

Pre-clinical studies ►

Pre-clinical studies ▼

▪ Overview

▪ Pilot and proof of concept studies

▪ Ocular efficacy studies

Clinical trials ►

Clinical trials ▼

▪ Overview

▪ Phase I

▪ Phase II - III

▪ Audits

▪ Patient and Investigator recruitme(...)

▪ Project management

▪ Medical writing

R&D support services ►

R&D support services ▼

▪ Animal model development

▪ Ocular histopathology

With 15 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 guidelines that 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