Case Study: Global Sourcing of Opdivo (Nivolumab) for an Oncology Study

Client Overview

A global biopharmaceutical company approached CSI to support a Phase III oncology study requiring Opdivo (nivolumab) as a comparator. The study spanned 4 countries across North America, Europe and Asia-Pacific, with a target enrolment of over 500 patients.

The client’s main objective was to ensure timely delivery of branded Opdivo for multiple trial sites while maintaining transparent, full chain of custody and documentation.

Challenge

There were several key sourcing challenges:

• Global availability constraints due to market-specific pack sizes and supply constraints in certain countries.

• Tight study timelines, with site activations beginning within 10 weeks of award.

• Import requirements across multiple regulatory regions (EU, US and Japan).

  
  

The open market procurement channels were unable to guarantee consistent supply across all territories.

CSI Solution

CSI leveraged its direct manufacturer relationships and global sourcing network to deliver a customized solution:

• Direct Sourcing: Opdivo was procured through manufacturer-approved channels ensuring standardised product quality across batches.

• Regulatory Support: CSI’s regulatory team managed Certificates of Analysis (CoA) and batch release documentation, ensuring compliance with each country’s import regulations.

• Global Distribution: Shipments were distributed through CSI’s depots in the USA, Germany and Singapore, optimizing lead times and minimizing logistics costs.

• Risk Mitigation: A dual-sourcing strategy was implemented to safeguard against regional shortages.

• Timeline Achievement: First deliveries reached depots within 7 weeks of study award, three weeks ahead of schedule.

Outcome

• Delivered on-time to all global depots.

• No temperature excursions during transit (Opdivo is a cold-chain product).

• Full traceability and documentation across all shipments.

• The client extended CSI’s sourcing services to additional oncology programs, involving Keytruda and Tecentriq.

Key Highlights 

Metric	Result
Study Scope	4 countries, 500+ patients
Product	Opdivo (Nivolumab)
Delivery Time	7 weeks from award
Compliance	Full CoA and batch traceability
Outcome	100% on-time delivery, no deviations

Conclusion

CSI’s ability to provide fast-tracked and agile global sourcing allowed the sponsor to accelerate study initiation and avoid unnecessary costs. Through trusted manufacturer relationships, scientific expertise and global, cold-chain logistics capabilities, CSI delivered a seamless comparator sourcing solution that reinforced the client’s confidence in partnering for future studies.