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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 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

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

A client approached CSI with a very specific request: to test samples of an expensive oncology product before purchasing the same batches that had passed the testing stage. This was a challenging assignment as it required visibility of batches currently on the market before purchasing, which is only possible in certain markets where product availability is moderate. Due to the nature of the trial, the client was not willing to disclose trial details and required documentation (Certificate of Analysis and Pedigree documents).

Solution

Without the possibility of disclosure, we had to source the product from the open market. This was challenging because we had to fulfil four requirements:


  • Batch testing

  • Advance visibility of batches

  • Product from specific batch available

  • Documentation


The most effective solution was to work with our audited suppliers to devise a ‘hit list’ of batches that had had a positive result in testing. This required close cooperation with suppliers in those markets where batch visibility and documentation were possible, to keep an up-to-date list of batches on the market at any given time, and whether they had had a positive or negative test.

Result

At CSI, we pride ourselves on implementing effective sourcing strategies for even the most complex trials. In this case, our high level of market knowledge resulted in the successful delivery of the required product and ensured the client’s trial never ran dry.


This type of sourcing strategy is dependent on very close communication between CSI, the client, and our suppliers. As suitable markets usually have limited availability, the product had to be collected over time before being delivered to the client in bulk. Guaranteeing a stable supply chain to the client, and ultimately the patient, was paramount at all times.


CSI also leveraged its strong relationships with suppliers to keep stock on hold, with the promise to purchase if the batch testing was successful. This solution is only possible when mutual trust exists between all parties, there is a deep understanding of the specific trial requirements, and you have a united team with the determination to deliver for the benefit of the patient.

Case Study

Oncology Product Batch Hunting

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

Challenge

To supply an oncology product for a client’s trial, with a caveat: a sample from each batch had to be tested before purchasing the bulk

Solution

We worked closely with suppliers to hunt specific batches in several European markets where batch visibility and documentation were possible

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

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