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

Sourcing Flu Vaccines for a Global Trial

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 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

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

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