More case studies
Challenge
CSI received an urgent request to supply a large quantity of a generic drug for an ongoing Phase 3 trial. These products were initially overlooked by the client as it was assumed the trial sites would supply them. When this was discovered to be unfeasible, the trial initiation date was already close, so the timescale to deliver the products – and keep the trial on track – was extremely tight.
Solution
We carried out extensive research to determine what drugs were licensed in the countries participating in the trial, which spanned three continents. All major generic manufacturers were approached to ensure coverage across all regions. Working closely with these manufacturers, CSI executed a literature review and obtained equivalency statements for the products required.
Approaching a wide range of manufacturers allowed CSI to present the client with a sourcing option that would cover all countries in the trial. The equivalency statements provided proof of clinical equivalency across products, which allowed the trial to proceed.
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
Overcoming Drug Shortages
How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial
Challenge
To supply a large quantity of a generic medication at the last minute for an ongoing Phase 3 clinical trial across three continents
Solution
A range of manufacturers were approached who could cover all trial countries, and clinical equivalency statements were successfully obtained
Result
CSI’s scientific expertise and knowledge of trial regulatory requirements delivered a strategy that enabled the client’s trial to begin without delay
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