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Rescuing a Global CRO’s Oncology Study with Cetuximab

Updated: Feb 5

How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market



Cetuximab is a type of monoclonal antibody, a targeted cancer drug used to treat advanced bowel cancer, and head and neck cancer, usually in combination with other anticancer treatments. In the United States, it was the first monoclonal antibody to be approved by the Food and Drug Administration (FDA) to treat patients with advanced metastatic colorectal cancer – i.e. cancer that has spread to other parts of the body.


Challenge

A listed global Clinical Research Organisation (CRO) approached CSI with the challenge of sourcing cetuximab with Certificate of Analysis (CoA) in Belgium, France, Italy, Spain and Czech Republic for a European oncology trial. The product in question was scarce on the market at the time and the client had recently been let down by a competitor, so supply timelines were extremely tight – the first shipment was required in less than 8 weeks. To make matters more complex, a quota system had been introduced for the product in some markets, with suppliers receiving only a small quantity of the product as stock was needed to supply the local market. Solution

CSI proved flexible in offering to start the work of sourcing and purchasing the product following receipt of email confirmation of the award of the study – before the client had even finalised the full scope of work and raised a purchase order – in order to condense timelines. We were then able to leverage our European supplier contacts to source the product very quickly and, within six days of the client’s original request, CSI had formed a comprehensive proposal for the client, including all costs for sourcing and distribution. Result

The CRO was able to proceed with their oncology study in Europe without delay to its timelines. CSI received glowing feedback from the client for its work in supporting this trial and has since been awarded further business from them.




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