Quality Assurance/Compliance

CCSA uses the most recent regulations, practices, and tools in our quality assurance program.

Experienced clinical quality assurance and compliance professionals provide a systematic approach to ensure compliance with FDA as well as with ICH/GCP guidelines. Our audit program includes in-depth audits of systems, investigator sites, and documents to certify GCP compliance.

We develop a client-specific audit plan to address each audit goal. A written report presented at the conclusion of each audit includes detailed observations and any required corrective action.

Our audit teams have played a major role in preparing clients for FDA inspections. We offer:

• On-site Clinical and Regulatory Audit
• Pre-study Audit of Protocol and CRFs
• Data and Database Audit
• Statistical Audit
• SOP and Systems Audit
• CRO Audit