Global Auditing Services

• GCP Vendor Audits: Full-Service CRO, Monitoring CRO, Data Management, Other (Central IRBs/EC), Phase 1 Units, Site Management organizations, Clinical Labs

• GCP Investigator Site Audits (Phase 1-4): Routine and For-Cause

• GCP System Audits: Clinical Operations process (e.g. monitoring, safety, clinical pharmacology, vendor oversight, IMP management, sponsor oversight, medical writing etc) and Local Operating Company process, Regulatory Affairs Process, End to End Study related systems, Data Management.

• GCP Phase I Audits and Assessments.

• GCLP Audits: Central and local labs

• PV Audits- Vendors and Marketing Partners

• GDP - Vendor audits