– Study/Trial Master Files audits
– Study documents (Protocol, ICFs, CSRs) audits
– Clinical Investigative Sites audits
– Clinical Databases audits
– Statistical Programming audits
– Pharmacovigilance audits
– 3rd party vendors audits (including PV call centers, bioanalytical laboratories, Phase I Units, CROs, translators, Ethics Committees, BABE centers etc)
– Corrective and Preventive actions (CAPA) program
– Process Audits