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*Some audits may be performed remotely where feasible
Routine/Directed audit of investigator site
Routine/Directed audit of CRO
Qualification or re-qualification of a CRO/Service Provider/investigator site for services
Routine GCP audit of study conduct at Phase 1 unit
Qualification or re-qualification of a Phase 1 unit
*Some inspection support may be provided remotely where feasible
General training, targeted review, evaluation of personnel and facility preparedness of potential inspection
On-site support during inspection
*QA support services may be provided remotely where feasible
Investigation, Root-Cause Analysis (RCA), and CAPA development/review
Standard Operating Procedure (SOP) review/revision against regulatory requirements
Consult for regulatory compliance issues, protocol compliance, ICH GCP, etc.
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