AUDITING

Pre-Clinical

All aspects of pre-clinical safety study performance including:

• System Development
• SOP Development
• SOP Review
• In-Life Procedure Audits
• Facility Audits
• Facility Qualification
• Documentation Audits
  Study Records
  Study Data
  Study Reports

Clinical

Investigational sites, specializing in pre-regulatory authority inspections both domestically and internationally.

• Sponsor activities and documentation including:

Study documentation
Completed case report forms
Clinical study reports
Regulatory submission summaries

• Regulatory authority preparation inspections for sponsors
• Pre-qualification of contract research organizations
• Contract research organizations for adherence to contractual requirements