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Clinical Services

Auditing

An audit is carried out to assess compliance with the clinical trial protocol, regulatory requirements, and relevant standards such as ISO 14155 and ICH GCP. The scope of an audit may cover the entire clinical trial or any piece therein, such as an audit of the CRO or an audit of a clinical trial site. Our expert clinical trial services team can assess the compliance of your clinical trial to ensure integrity of the trial data, documentation, and procedures. We will help identify potential risks to address proactively issues that could jeopardize the clinical trial or its results. Along with a report of the audit findings, we also provide recommendations based on best practices to improve compliance or to improve your quality systems and procedures themselves. Our team can walk you through the process of implementing these enhancements and even provide clinical trial staff training to avoid issues in the future.