Conducting audits early in the clinical stages of development identifies systematic problems with the conduct of your study, such as misinterpretation of protocols. These audits enable early intervention and corrective action to avoid preventable delays and expense in the conduct of your program.

• Our auditors have expertise in indigenous country requirements as well as FDA/ICH clinical research requirements.
• Our QA personnel are accustomed to working as a team with your organization. At no additional cost to clients, we share information on mutually agreed audit plans and discuss QA and compliance issues with you.

We offer:

• Individual site audits
• Document audits
• Internal system audits — audits of SOPs, documents and staff training for improvement of efficiency and compliance
• Investigator-directed audits — investigation of questionable data for clients
• Team members have hands-on experience in FDA audits
• Vendor audits of subcontractors, such as central lab investigational study materials
• QA consulting
• We can provide independent auditors when requested