top of page
Contact Us
Contact Us

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’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

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

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

Contact us 

bottom of page