More case studies
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:
No product was licensed in all countries where the trial was running
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.
Case Study
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
To supply grass pollen allergen tests for a global clinical trial in which no product was licensed in all trial countries and a considerable quantity of a single product was required
Solution
CSI researched an equivalent unlicensed product that was successfully submitted to all country regulators and could be sourced in large quantities from an independent manufacturer
Result
Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy, ensuring the supply of a high volume of a single product so the study could run to schedule
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