ABS' client, engaged in a clinical trial, encountered an unforeseen issue when their contracted Clinical Research Organization (CRO) couldn't store collected samples. Faced with urgency, the client had to decide between outsourcing storage or managing it in-house. However, their in-house facilities were not suitable for the task, lacking restricted access and the necessary expertise for sample management.
The client faced several challenges, including:
- Limited options for storing clinical trial samples after the CRO's unexpected issue.
- Inadequate in-house facilities, with a freezer used for daily lab activity.
- Lack of expertise for proper cataloging and maintenance of an audit trail for clinical trial samples.
Given ABS' existing management of non-clinical sample storage, the client approached ABS for a solution. ABS promptly provided a logistical solution, ensuring secure storage that protected samples from quality issues related to temperature variations due to frequent freezer access. ABS' sample database was leveraged to establish a comprehensive audit trail, addressing potential FDA inquiries.
The collaboration with ABS resulted in:
- Swift and secure storage for clinical trial samples.
- Protection against quality issues arising from temperature variations.
- Expert cataloging and maintenance of an audit trail through ABS' sample database.
ABS' rapid and secure solution resolved the client's challenges in clinical trial sample storage. This case study emphasizes the value of a prepared and experienced partner in safeguarding the integrity of critical trial samples throughout their life cycle.
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