GCP Audits

Our Quality Assurance staff is highly skilled and experienced. Effective Research provides the following GCP auditing services in the United States to assure compliance with FDA regulations, GCPs, ICH Guidelines and applicable SOPs:

• Investigator Site Audits
• Regulatory Document File Audits
• Database Audits
• Integrated Clinical/Statistical Report Audits
• Package Insert Audit
• ISS and ISE Audits
• Systems and Process Audits
• Clinical Laboratory Audits
• Pre-FDA Inspection Readiness Audits