Clinical Trials & Pharmaceuticals

  • Summaries of Product Characteristics
  • Protocol Summaries
  • Clinical Trial Applications
  • Informed Consent Forms
  • Investigator’s Brochures
  • Patient Materials (Appointment reminder cards, posters, etc.)
  • Patient Reported Outcome Instruments
  • Standard Operating Procedures
  • REB/IRB Correspondence and Documents
  • ANSM/AFSSAPS Correspondence and Documents
  • Clinical Trial Approvals/Annual Reapprovals
  • Serious Adverse Event/Reaction Reports
  • Back Translations
  • Package Inserts/Labels
  • Instructions for Use
  • Patient Instructions