top of page

Investigator/Study Site Audits

  • CQMP, Protocol, applicable regulations and guidelines, and sponsor/CRO SOP compliance 

  • Audits of submission for ethical approval for clinical trials

  • Site/facility inspection

  • Site personnel training and qualifications

  • PI availability and oversight 

  • IRB interaction procedure review

  • Review Adverse Event (AE) reports, Informed Consent, safety and subject enrollment criteria 

  • Review Case Report Form and Source Data

  • Preparation for ISO 9001 (Quality Management Standard) inspections 




GCP Audit

Good Clinical Consultants - GCP Audits, QMS

GCC will: 

Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs. 

Review computer systems procedures and documentation, including those for security, back-up, and recovery 

Review QA unit reporting structure, auditing practices, and CAPA procedures

bottom of page