The clinical trial supply chain is a complex, multistep process with the inherent risk of failure present at every stage in the drug development cycle. It is by no means a simple task to bring all parties together in the correct order to create a coherent, stable flow. A core planning structure must be in place and carefully evaluated to ensure clinical trial success. For clinical logistics to run smoothly, it is important to recognise all dependencies and assess supply chain risks in advance so as to temper them.
One of greatest challenges for contract research organisations (CROs) managing clinical trials and the supply chain is the seamless incorporation of specialised third party suppliers
One of greatest challenges for contract research organisations (CROs) managing clinical trials and the supply chain is the seamless incorporation of specialised third party suppliers, such as manufacturing companies, focused on primary and secondary packaging of investigational medicinal products (IMPs) and other clinical trial materials. Small delays to production timelines are not uncommon and can cause significant overspending. Understandably, when delays occur at one stage in the supply chain, the impact can be felt by every forward link. Costs escalate quickly and the likelihood increases of additional study delays.
Typically, this outcome is due to poorly controlled connections or the absence of a manufacturing supply strategy. Advance planning based on valid trial protocols is essential for avoiding insufficient product quantities or manufacturing capacities.
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