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Research compliance audits: Where to begin?

Sharif Fakhr (sharif.fakhr@ankura.com) is a Managing Director in the New York office, Draco Forte (draco.forte@ankura.com) is a Director in the Chicago office, and Nicole Visyak (nicole.visyak@ankura.com) is a Senior Director in the Boston office of Ankura.

With increases in government oversight, proper auditing and monitoring of clinical research is critical for any research program or organization. It has become increasingly evident that a comprehensive research compliance program is not only recommended, it is expected. Research organizations and the researchers involved must understand the multitude of regulatory requirements, best practices, and compliance risk areas to be effective and efficient in performing clinical research. However, the reality is that it is impossible to audit and monitor all risk areas simultaneously. Prioritization of where to focus time and material resources can be an overwhelming task.

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