Delivering Comparators for a Global Allergy Study

How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries

Challenge

CSI was asked to support a client’s clinical trial by supplying grass pollen allergen tests to many different countries. There were two main concerns:

1. No product was licensed in all countries where the trial was running

2. The same product had to be used for all patients to ensure consistency in trial results and the sponsor was concerned about sourcing the considerable quantities required within the timeline necessary to support the trial

Solution

CSI carried out an extensive review of the available literature, gathering evidence on products that were considered equivalent, having largely the same composition to the original product. The licensing aspect was further clarified as the use of unlicensed products was common in many markets.

Due to the request for a large quantity of the same product, the optimal sourcing strategy was identified as a central model direct from a manufacturer, rather than relying on local sourcing from many different countries. CSI decided the most suitable option was to approach two independent manufacturers to protect the supply.

Result

Using the evidence gathered by CSI on equivalency across products and the use of unlicensed medication, the sponsor submitted with the two products to country regulators successfully.

Approaching two manufacturers was prudent as one manufacturer could no longer support the required quantity at the time of order due to changes in production. Securing a second manufacturer who was able to support the requested volume meant the study ran to schedule.

Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy and provided a safety net in the form of a back-up option. The scientific expertise that CSI has was crucial to allowing the trial to follow a central sourcing model, minimising the risk of shortages in supply by only sourcing from one market.

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