Axis International is experienced in performing GCP/ICH quality assurance auditing (QA) and quality control review (QC) for phase II - IV clinical trials.

Axis QA and QC auditing services further defined:

  • QA Audits of clinical study reports (CSR)
  • QA Audits of integrated summary of safety (ISS) reports
  • QA Audits of integrated summary of efficacy (ISE) reports
  • QA Audits of serious adverse event (SAE) narratives
  • QA Audits of tables/listing/graphs
  • QA GCP/ICHs audit of clinical investigator(s) site
  • QA Audits of clinical database
  • QC of NDA clinical sections
  • QC review of regulatory documents submitted from CRO on behalf of sponsor(s)
  • QC in-field evaluation of CRO monitors on behalf of sponsor(s)
  • QC review of CRO monitoring trip reports on behalf of sponsor(s)




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