A Clinical Supply Chain Management Solution Designed For Clinical Research

A clinical supplies manager at BestPharm was working to prove the efficacy of a new Oncology drug candidate, CP-4582. Originating in Wuxi, China, the manager's expansive global supply chain commences its journey. At this location, a factory meticulously produces the essential initial materials, which subsequently find their way to an API manufacturing facility nestled in Switzerland. The resulting drug substance, an outcome of this intricate process, embarks on a voyage across continents, arriving at a specialized drug product manufacturing establishment situated in the northeastern United States. It is here that the substance is further transformed, shaping it into its final form.

However, the journey does not conclude here. The meticulously crafted drug substance then travels to a distinguished packaging company located in the heart of the Midwest United States. This final leg of the expedition involves the assembly of meticulously labeled patient kits, each a crucial component in the distribution chain. These kits are meticulously prepared and primed for their ultimate purpose: delivery to various sites where they will play an indispensable role in the healthcare ecosystem, contributing to the well-being of patients.

With the company working tediously to expand, there are high stakes to ensure every supply chain decision is carried out efficiently. But, what happens when the transfer team identifies
a genotoxic impurity that’s contaminated the drug substance batches over the past two years? As required by law, the manager notifies the FDA, who ask for a full traceability report and product recall within 24 hours to ensure no more participants are at risk of receiving the contaminated drug substance.

All five RTSM systems are immediately placed on hold for each of the five studies, freezing
dispensation and blocking administration of site visits. Because RTSM systems don’t reflect batch genealogy, the manager will also have to systematically retrace all input batches to determine where her supply chain has been contaminated.

Access the full case study to learn how the manager was able to utilize GxP Inventory to replace fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.