Streamlined Vendor Management and Audit Preparedness for a Mid-sized CRO

Overview

In clinical research, meticulous vendor management ensures compliance with regulatory standards and data integrity. ACL Digital Life Sciences assisted a mid-sized Contract Research Organization (CRO) when it faced a critical challenge. Several vendor re-qualifications were not completed as planned, posing a significant risk of non-compliance with regulatory requirements (ICH-GCP, FDA, EMA). With an impending sponsor audit, the CRO sought swift resolution to mitigate risks and uphold regulatory obligations.

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Challenges

Delayed vendor re-qualifications jeopardizing data integrity and regulatory compliance

Impending sponsor audit necessitating swift resolution to demonstrate preparedness

Need for a practical solution to address delays and mitigate compliance risks effectively

Solution

Gap Analysis: A comprehensive analysis identified the root cause of the problem: a lack of risk-based prioritization within the re-qualification process
Risk-based Re-qualification: The existing vendor re-qualification process was revamped to prioritize critical andmajor risk vendors handling patient and clinical trial data. This ensured timely re-qualification for the most crucial vendors
Deviation Management: A detailed deviation list for delayed re-qualifications was prepared. This list assessed the impact of each delay and outlined corrective actions
Knowledge Transfer: A workshop equipped the CRO’s vendor management team with the revised process and immediate action items to address the upcoming sponsor audit. Additionally, long-term strategies for continuous improvement were discussed