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

Overcoming Drug Shortages

Challenge

One of our clients, a leading T Cell Receptor (TCR) biotechnology company, has several biological therapy products in development for a range of oncology and autoimmune indications. They also conduct first-in-class research into new treatments for infectious diseases utilising their pioneering immunotherapies.

 

The client approached CSI while running clinical trials in many different countries for an investigational product that is administered in conjunction with saline and human serum albumin (HSA). CSI was approached to evaluate and provide evidence so that our client could move from a central model to a local sourcing model for these ancillary products.

 

There are a wide variety of saline and HSA products available in the trial countries, each with different bag or container materials. Since there was limited stability data regarding the equivalency of local products, the client initially had to source all saline and HSA centrally. This had a significant impact on costs and logistical complexity. While saline and HSA bags or containers are inexpensive, they are bulky and heavy products, so a central sourcing model increases overhead costs and adds complications and potential delays to the supply chain. In this case, the saline and HSA had to be relabelled to reflect the language of each trial country, which added yet more expense and complexity to the undertaking. 

Solution

CSI provided scientific insight regarding the different types of bag or container materials that are marketed and used to carry saline and HSA, as well as the different strengths of HSA available across the large number of countries in the trial, including:

 

  • Australia

  • Canada

  • France

  • Germany

  • New Zealand

  • Russia

  • Ukraine

  • United Kingdom

  • United States

 

The range of products was diverse and included rigid containers and flexible bags made from a variety of materials, including polyethylene (PE), polypropylene (PP), PE/PP copolymers and blends, and polyvinylchloride (PVC).

 

CSI sourced quantities of these products in different pack sizes and from different countries, covering the full range of materials used. Our client then carried out analytical testing to confirm the compatibility of their investigational product with each type of container material and the different strengths of HSA.


Result

After confirming the compatibility of their investigational product with the different saline and HSA bag or container products, our client migrated to a local site sourcing model for the saline and HSA used in their trial.

 

This averted the need to centrally source and distribute these heavy items, creating a much simpler, more efficient, agile and cost-effective supply chain. In addition, the core product became easier to use and more attractive since no specific ancillaries were required for its administration. This resulted in very significant savings for the duration of the study.

Case Study

Streamlining Biotechnology Supply Chains

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

Challenge

To help a leading biotechnology company transition from a central to a local sourcing model for ancillary products for a global clinical trial

Solution

CSI provided the client with all available products in the trial countries around the world for compatibility testing with their investigational product

Result

The client migrated to a local site sourcing model, creating a much simpler, more efficient, agile and cost-effective supply chain

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

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