To support Good Clinical Practice (GCP) and ensure clinical trial quality and integrity, sponsors need to conduct investigator site audits. However, due to resource constraints, it is not possible to audit every site in a clinical trial, and those that are selected for audits need to be selected based on a variety of risk factors. To improve audit site selection efficiency and accuracy, a shift towards data-driven is needed.

Goal

To outline data-driven strategies for the selection of clinical trial sites for audits based on a comprehensive evaluation of risks.

Expected Outcomes

  • Promote the use of analytics and data-driven approaches for clinical site audit selection across the pharmaceutical industry.
  • Position paper outline the challenges, opportunities and data-driven strategies for the selection of clinical site audits.

Leads

Resources

Transforming Trial Audits: A Deep Dive Into Data-Driven Clinical Site Audit Selection in Pharmaceuticals

Published in RQA QUASAR #169, November 2024 – Transforming Trial Audits: A Deep Dive Into Data-Driven Clinical Site Audit Selection in Pharmaceuticals. The paper was led by the Audit Site Selection Work Product Team, which includes authors Hangyu Liu, Elina Beletski, Michael Pelosi, Ofure Obazee, Bjorn Koneswarakantha, and Lucie Regne-Martos. The Work Product Team consists of 10+ IMPALA biopharmaceutical Member Organizations, each providing input on the evolution in data-driven clinical site audit selection in the pharmaceutical industry. This white paper delves into the transformative shift from traditional data-driven methods to more advanced strategies, exemplified by the challenges of automating clinical site audit selection and giving insights into the current practices of the IMPALA consortium member companies. It highlights the need for continuous innovation and industry collaboration to fully realize the potential of data-driven methodologies in enhancing the quality and integrity of clinical trials. In the article, IMPALA Members share a vision for a data-driven clinical site audit selection, led by innovative and efficient processes that revolutionize the quality assurance approach in clinical trials, to be safer, more compliant, and more successful.