With regulatory inspections on the rise, you need to be sure your site adheres to the most stringent requirements for compliance and patient protection. Our rigorous auditing process is designed to identify and address issues before the FDA finds them and prepare your team to answer questions with confidence.
Our auditing services are based on the FDA’s BIMO checklist and cover every aspect of your site, including protocol, IRB requirements, agreements, sponsor requirements and standard operating procedures. In addition to site GCP audits, we also provide sponsor/CRO audits and vendor qualification audits.