Clinical Managers – Do you have an upcoming FDA audit? Is your study documentation a mess? Not sure if your monitoring is adequate? Worried FDA might knock on your door sooner rather than later?
Bannick has the experience and know-how to improve your team’s audit readiness. Here are three ways we can help:
- Routine pre-BIMO audit of your study at the site or sponsor level. After meeting with you to understand your goals, we develop an audit plan, conduct the audit (using FDA’s guidance), and deliver an audit report. We can meet with your team afterward to discuss findings and recommendations.
- Mock BIMO audit to prepare your team for an anticipated FDA inspection. This entails a Bannick consultant assuming the role of an FDA inspector and conducting an audit as FDA would. This is a great way to practice your processes for handling an audit between your front and back rooms. Pauses or “time-outs” can be taken for in-audit coaching as you wish.
- Audit training to ensure your team is prepared for any audit.
If you would like to learn more about how clinical quality audit services can help you achieve your study objectives, Bannick LLC is your experienced Clinical partner. Our Clinical Quality Services are tailored to help you achieve your goals.
Visit our website at bannickprimary.com or contact us at info@bannickprimary to schedule a FREE 15-minute consultation.
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