Reliable Global Opdivo® Comparator Supply
CSI has extensive experience purchasing Opdivo®, supplying the medicine to clinical trials worldwide. We support oncology studies across Europe, North America, Latin America and Asia‑Pacific, providing reliable comparator sourcing backed by an established global supply network.
As an expert supplier of Opdivo® (nivolumab), CSI understands that it is commonly supplied alongside complementary oncology therapies, including Ipilimumab (Yervoy®), Carboplatin, Cisplatin, Gemcitabine, Paclitaxel, Pemetrexed and Cabozantinib (Cabometyx®). We have tremendous experience and expertise in sourcing these medicines, providing clients with a reliable, streamlined solution for the procurement and supply of combination therapies required for clinical trials.
Opdivo® (nivolumab) Comparator Sourcing
The clinical supply partner of choice
CSI supports global oncology studies requiring Opdivo® (nivolumab) for their comparator medicine through an established international sourcing network. We work with sponsors to secure authenticated product with full documentation while ensuring continuity of supply for long-term development programmes.
Our team can support:
Multi-country studies
One coordinated supply strategy across every participating country. We will tailor the best sourcing method for your requirements, between local sourcing, central sourcing and hybrid sourcing.
Manufacturer-direct sourcing
Direct relationships with manufacturers and licensed wholesaler networks.
Cold chain logistics
GDP-compliant temperature-controlled distribution with continuous monitoring and excursion reporting.
Regulatory documentation
The full documentation set supplied with every shipment for your QP and regulatory teams.
Forecast planning
Volume planning across the study lifecycle so supply is secured ahead of enrolment peaks.
THE CSI PROCESS
From protocol to site in six steps
Six steps, one project manager providing end-to-end support.
01
Protocol Analysis
Our scientific team reviews your protocol, designs the optimal comparator sourcing strategy tailored to your study design. You get a comprehensive clinical trial supply solution, not a price list.
02
Availability
We review all the optimal sourcing markets, batch availability, shelf life and pricing across a network of more than 200 audited manufacturers and suppliers, and remove any option where continuity is at risk.
03
Sourcing and authentication
The product is purchased with consideration of multiple factors (the number of supply runs required based on the shelf life of the product and length of your study, supply per arm and per visit schedule). These are purchased either manufacturer-direct or through the open market. Every unit is quality-checked at purchase and when it enters our depots.
04
QP release and documentation
CSI can provide Statement of Authenticity (SoAs), Certificate of Analysis (CoA) (product priced accordingly), and in some cases, BSE/TSE statements, equivalency statements, certificate of compliance, and batch-release certificate, upon request. For a fee, CSI can also provide a Certificate of Origin (CoO).
05
Cold chain delivery
CSI can handle all temperature-controlled logistics requirements, with continuous temperature monitoring and GDP-compliant handling across 61 countries on six continents.
06
Resupply and forecasting
Rolling demand forecasts, shelf-life control and batch reservation for the life of the study, with one project manager accountable from first shipment to reconciliation.
PRODUCT DETAIL
Presentations we supply
40 mg
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Presentation
Route
4 mL vial (10 mg/mL)
IV infusion
100 mg
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Presentation
Route
10 mL vial (10 mg/mL)
IV infusion
COLD CHAIN
CSI supports all temperature requirements
Opdivo ships at 2 to 8°C, but some clinical trials require more than one comparator at a time. CSI covers the full range so all supplies move together.
15–25°C
AMBIENT
Qualified logistics partners, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
2 to 8°C
REFRIGERATED
Qualified shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
−20°C
FROZEN
Fully audited shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
−80°C
ULTRA-LOW
Qualified shippers, continuous temperature monitoring and excursion reporting, GDP-compliant end to end.
Why sponsors choose CSI
150+ years of clinical trial supply experience and a scientific team that reads the protocol before it quotes.
Over 1,200 clinical trials supported
Direct relationships with 200+ manufacturers
Dedicated scientific project management team
Expertise in oncology, biosimilars, immunology and ophthalmology
Access to 15,000+ medicines
Warehousing and distribution across 61 countries
GDP-compliant cold chain at every temperature
Full regulatory documentation with every shipment
Documentation
CoAs can be supplied upon request, in the language your regulatory submission requires. Products supplied with a CoA may be subject to higher costs.
Formal confirmation that the batch was released for supply in its licensed source market under the manufacturer's quality system. Upon request, this can be supplied alongside the Certificate of Analysis, so your QP can trace release back to the licensed market.
A signed declaration that the product is genuine and was acquired through the licensed supply chain. This is the assurance against falsified or diverted product when a comparator is bought on the open market.
Monitoring data for every shipment, reported and assessed for impact on product quality. You receive the record whether or not an excursion occurs.
CASE STUDY
Global Sourcing of Opdivo (Nivolumab) for an Oncology Study
How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets.
Challenge
Global availability constraints, tight timelines with site activations within 10 weeks, and import requirements across the EU, US and Japan
Solution
Manufacturer-approved sourcing with full CoA and batch release documentation, distributed through CSI depots in the USA, Germany and Singapore
Result
First deliveries reached depots seven weeks from award, three weeks ahead of schedule, with no temperature excursions and full traceability
APPLICATIONS
Where sponsors use Opdivo® as comparator
Oncology
Comparator and standard-of-care supply for solid tumour and haematology programmes across all phases.
Immunotherapy
Checkpoint inhibitor sourcing for combination and head-to-head study designs.
Biosimilar development
Originator reference product sourced to meet regional regulatory requirements.
FAQ
Opdivo® sourcing, answered
Can CSI supply nivolumab (Opdivo®) as a comparator for a global study?
Yes. CSI sources Opdivo® for oncology trials across Europe, North America, Latin America and Asia-Pacific. Our scientific team reviews your protocol, models quantities and builds a country-by-country sourcing strategy before any purchase is committed.
CSI understands that it is commonly supplied alongside complementary oncology therapies, including Ipilimumab (Yervoy®), Carboplatin, Cisplatin, Gemcitabine, Paclitaxel, Pemetrexed and Cabozantinib (Cabometyx®). We have tremendous experience and expertise in sourcing these medicines, providing clients with a reliable, streamlined solution for the procurement and supply of combination therapies required for clinical trials.
Which presentations of nivolumab are available?
Presentations vary by source market and are confirmed against your protocol before quotation. Price, expiry and availability are confirmed prior to the receip0.t of a Purchase Order.
How long does comparator sourcing for nivolumab take?
Every study is different, and sourcing timelines depend on your specific requirements, market, quantity and documentation needs. Send us your study requirements and product details, and we will assess what is possible for your programme.
What documentation is supplied with the product?
The availability of supporting documentation depends on the country from which the product is sourced and the specific requirements of the study. Where available, CSI can provide documentation such as Certificates of Analysis and country-specific regulatory documentation at an additional cost.
How is cold chain managed for nivolumab?
Nivolumab is shipped at 2-8 °C with continuous temperature monitoring, through GDP-compliant depots in 61 countries. CSI also manages ambient 15-25C, -20 °C and -80 °C requirements for other components of your study.
Send us the protocol, the markets and the timeline. Our scientific team will come back with a sourcing strategy for your Opdivo® requirements.
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