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Quality Assurance

Integrity assured

Let us audit your clinical studies (site and in-house files) to ensure adherence to FDA (Food and Drug Administration) regulations, ICH (International Conference on Harmonization) guidelines, and GCPs (Good Clinical Practices) and to verify the integrity, completeness and accuracy of your data

Services

  • Audit clinical site files
  • Audit internal study files
  • QA/QC of regulatory documents
  • QA/QC of study reports
  • QA/QC of submission documents