Iris Pharma is a Contract Research Organization ( CRO) specializing in clinical research in ophthalmology. Our clinical trial services bring together an extensive network of professionals with experience in undertaking clinical trials in ophthalmology in Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, India, Israel, Italy, Morocco, the Netherlands, Poland, Portugal, Romania, Saudi Arabia, Spain, Switzerland, Tunisia, Turkey, United Kingdom and the USA.

Services offered by Iris Pharma for clinical trials and clinical development include:

• Strategic trial planning
  • Study drug development consulting
  • Study feasibility and design
  • Support to investigators for non-commercial trials

• Regulatory requirements
  • Files for submission to Ethics Committees according to local laws and the European directive (including e-submission using EudraCT database) and to competent authorities for regulatory approvals

• Medical writing
  • Writing protocols and study summaries
  • Writing investigator´ brochures
  • Review of the Investigational Medicinal Product Dossier (IMPD)
  • Design of Case Report Forms (CRFs) and transcription to electronic Case Report Forms (eCRFs) if required
  • Design of patient diaries
  • Clinical study reports
  • Publications

• Clinical operations
  • Selection of coordinating investigators and other investigators
  • Site coordination
  • Management of biological samples
  • Management of investigational medicinal products
  • Clinical monitoring according to GCP/ICH guidelines
  • Investigators meetings and newsletters
  • Safety surveillance
  • Audits of centers
  • Management of fees for investigators and hospitals
  • Biometry (data management / statistics)
  • Archiving