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More case studies

Export of expensive comparators from Europe to China with first leg documents and streamlined approach

CSI’s seamless comparator export to China

How CSI’s flexible approach to global distribution ensured a large biotech’s three-year study across 15 countries could proceed without delay

Global Medical Device Distribution

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

Rescuing a Global Biotech's Oncology Study with Cetuximab

How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price

Delivering €1 million Savings for Pembrolizumab

How CSI supplied large quantities of ruxolitinib to a CRO’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments

Global CRO Oncology Partnership

How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial

A Quality Solution to Clinical Trial Supply

How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets

Oncology Product Batch Hunting

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

Delivering Comparators for a Global Allergy Study

How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline

Rapid Oncology Study Supply

How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial

Streamlining Biotechnology Supply Chains

How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial

Overcoming Drug Shortages

Challenge

CSI was approached to support a quadrivalent influenza vaccine study running in multiple countries in the Northern Hemisphere. The sponsor wanted to use the same product across all participating countries in the trial.

 

Due to the seasonal nature of this vaccine, there is only one production run per year, which takes place each summer: manufacturers look at predictions from the World Health Organization for what the dominant flu strain will be the following winter and produce vaccines accordingly. The vaccine doses are typically booked well in advance by customers – around January – and there is very little oversupply.

Solution

When our client was ready to run the study, several manufacturers in the United States were already overbooked versus their production and would not have been able to support the requirements of the trial in all regions.

 

CSI was able to leverage its longstanding relationship with a major European manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer, CSI demonstrated the equivalence of the EU and USA products. The trial also ran in some South East Asian countries; in order to bypass tricky import requirements, CSI sourced the product locally in these countries.

Result

With a flu vaccine trial, getting the sourcing wrong can be very costly. Failure to secure supplies would postpone the trial by a full calendar year since the Southern Hemisphere is a poor option when it comes to running a flu vaccine trial, having fewer countries and a circulation of poorly defined flu strains.

 

CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the entire study. Without this strategy, the trial would have been delayed by one year at great expense to the sponsor.

Case Study

Sourcing Flu Vaccines for a Global Trial

How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule

Challenge

To support a quadrivalent flu vaccine study by sourcing doses of a single product that was in short supply and managing delivery to multiple countries around the world

Solution

CSI’s relationship with an EU manufacturer secured the product in the quantity required for the whole trial, and equivalence between the EU and USA products was successfully demonstrated

Result

The time-sensitive study was safeguarded through a combination of CSI’s sound scientific and regulatory advice, and delivery of a robust sourcing solution

Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements

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