Article | August 18, 2024

Better Audits, Faster Through Transparency And Efficiency

Source: OpenClinica

By Laura (Loa) Keita

GettyImages-1245953899 IRB compliance

The clinical trial industry has made significant strides in data management, transitioning from paper-based to electronic systems. However, the audit process, a crucial component of quality assurance, has remained largely unchanged. Traditional audits, characterized by rigid timelines and limited access to documentation, often hinder efficiency and thoroughness. In this article, Laura Keita, Sr. Director of Compliance at OpenClinica, advocates for a new approach: a transparent, open-access model that empowers auditors to conduct more comprehensive reviews while reducing the overall audit burden.

By sharing insights into OpenClinica's innovative audit process, Keita challenges industry norms and proposes a blueprint for a more efficient and effective future.

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