Clinical Study
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Medical Affair Consultancy/ Clinical Study

  • GCP compliance study
  • Protocol Design
  • IRB submission
  • Project management
  • Monitoring
  • Final Report

Medical Devices with significant risk or some medical devices with non-significant risk (such as contact lenses) may require clinical evidence to prove the safety and effectiveness. A clinical study normally require doctors, researchers, regulatory affair or clinical research associate, statisticians and others to work together. A contract research organization could provide protocol writing, IRB submission package preparation, project management,clinical monitoring and clinical study report in accordance with GCP Good Clinical Practice. Our experienced clinical expertises are familiar with the GCP regulation and ISO 14155 and we could help you to collect  valid clinical data in an efficient way.