Clinical Research Documents

  • Development of Clinical Reseach documents
  • Protocols
  • Clinical Research Forms
  • Informed Consent Forms
  • Support material for monitors, sites/coordinators, pharmacies
  • Inclusion and Exclusion criteria pocket cards
  • Procedures schedules
  • Logs such as drug dispensing and drug accountability
  • Monitoring Plan (100% or reduced monitoring)
  • Study drug labels following each country’s Regulations
  • Translations/reviews of Clinical Research Documents
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