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.
