Most pharmaceutical and biotech companies outsource the management and conduct of their clinical trials to a CRO. Although Sponsors can delegate tasks to a CRO, they continue to be responsible for subjects’ safety and compliance to the regulatory requirements. So how can sponsors ensure that the clinical trials are being conducted correctly?
Auditing the CRO will provide reassurance that the company is conducting the clinical trial(s) in accordance with requirements. Understanding how to effectively prepare for, conduct and close out the audit will increase your chances of gaining buy-in and getting the information you need.
Join us for an interactive webinar that provides participants with a working knowledge of how to conduct an effective audit to determine compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.
By attending this interactive live session, you will be able to:
- Prepare for an audit by deciding what/when to audit, how to gain support and properly schedule the audit with the CRO.
- Perform a productive audit by determining what documentation to review, what questions to ask, how to assess compliance and how to properly debrief.
- Effectively close-out the audit by writing and filing a report, following up on activities and providing a certificate.