We can perform audits globally and offer services on a ‘one-off’ audit basis or for a program of audits e.g., for a clinical trial audit program.

Our range of audit services covers the following GxP disciplines:

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Good Clinical Laboratory Practice (GCLP)

The type of audits we execute include:

  • Investigator Sites – Phase 1 – 3
  • Contract Research Organisations (CROs)
  • Clinical and contract laboratories
  • Contract Manufacturing Organisations (CMOs)
  • Archive service providers
  • Software companies
  • Computer System Validation (CSV)
  • Internal Process/System 
  • Data Management 
  • Document audits (e.g study protocol audits and CSR audies)

In the event of travel restrictions we can perform remote audits where travel to the site is not possible.

Auburn Klein Consulting, Auditing,

Work With Us

To learn more about how we can help you and your organisation contact us for a discussion on your business needs. We can be contracted by phone, email or you can send us a message.