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Conducting a Data Quality and Integrity Audit for a Biopharmaceutical Company

Clarkston Consulting recently partnered with a biopharma client on a data quality and integrity audit. Read a synopsis of the project below or download the full case study.

Download the Biopharma Data Quality and Integrity Audit Case Study

In this biopharma data quality and integrity audit case study, Clarkston Consulting assisted a client as they prepared for upcoming clinical trials data readouts. The client, a biopharmaceutical company focused on identifying and developing innovative drugs for the treatment of patients with chronic and life-threatening conditions, is based in the United States with its subsidiary and manufacturing facilities located in China.  

Clarkston’s Quality and Compliance experts were engaged to evaluate the company’s data quality and integrity processes, procedures, and technologies specific to the database lock to topline results process. Key deliverables produced include an audit plan, audit checklist, and audit report. Clarkston’s methodology categorized observations across 13 categories informed by data quality and integrity leading practices and industry guidance. 

Clarkston worked alongside the company’s Internal Audit group to facilitate interviews with subject matter experts and verify their understanding of existing processes and their operating effectiveness. Clarkston’s audit team also reviewed SOPs, forms, templates, and executed documentation from a recent database lock, as well as documentation associated with vendor oversight, cybersecurity, data migration, and system validation. From these assessments, Clarkston identified potential risks and improvement opportunities as well as outlined recommendations to improve the security and reliability of this company’s data. These recommendations were categorized based on their level of risk and the effort required to implement them.  

Clarkston then met with the management team to review the audit and discuss their responses. Based on these discussions, the team determined quick wins and planned long-term initiatives for remediation as needed. As a result, the company was able to implement data quality and integrity improvements to its database lock to topline results process in advance of its upcoming database lock and identify key areas for improvement in the future. 

Download the Biopharma Data Quality and Integrity Audit Case Study, and learn more about our Quality and Compliance Services by contacting us below. 

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Contributions by Elli Alexander

Tags: Case Study, Data Integrity, Quality Operations