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)