Reliable global Opdivo® (nivolumab) comparator supply
CSI supports global oncology studies requiring Opdivo® comparator medicines 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.
Opdivo® (nivolumab) Comparator Sourcing
The clinical supply partner of choice
nivolumab is on the critical path of a large share of active oncology programmes, and demand routinely outstrips the volume available through a single market. Sponsors running multi‑country studies need a partner who can hold continuity of supply across regions, not a broker who can fulfill one order. CSI's scientific team builds the sourcing strategy around your protocol: which presentations the sites require, which markets can supply them compliantly, and how far ahead the volume has to be secured. That work is what keeps a study on schedule when the market tightens. Every unit arrives with the documentation your QP and regulatory teams expect, sourced through qualified manufacturers and wholesalers inside a fully traceable chain.
THE CSI PROCESS
From protocol to site in six weeks
Six steps, one project manager, full documentation at every handover.
Protocol and brief
Our scientific team reviews your protocol, confirms the comparator specification and models quantities per country, per arm and per visit schedule. You get a written sourcing strategy, not a price list.
02
Feasibility and market mapping
We map licensed markets, batch availability, shelf life and pricing across a network of more than 200 audited manufacturers and suppliers, and flag any market where continuity is at risk before you commit.
03
Sourcing and authentication
Product is purchased manufacturer-direct or through audited wholesale channels, with full chain of custody from the point of manufacture. Every unit is authenticated before it enters our depots.
04
QP release and documentation
Certificates of Analysis, chain of custody, purchase invoices and country-specific regulatory documentation are assembled for import and Qualified Person release in each destination market.
05
Cold chain delivery
Validated 2–8 °C shipping to depot or direct-to-site, with continuous temperature monitoring and GDP-compliant handling across 60 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.
What every Opdivo® order gets from CSI
Multi-country studies
One coordinated supply strategy across every participating market, not a purchase order per country.
Manufacturer-direct sourcing
Direct relationships with manufacturers and licensed wholesalers, with the route documented.
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.
COLD CHAIN
Three temperature regimes, one validated
nivolumab ships at 2 to 8°C, but a comparator programme rarely ships one product alone. CSI validates the full range so combination and concomitant supply moves together
2 to 8°C
REFRIGERATED
Opdivo® and the majority of biologic comparators. Continuous monitoring, qualified shippers, excursion reporting.
−20°C
FROZEN
Opdivo® and the majority of biologic comparators. Continuous monitoring, qualified shippers, excursion reporting.
−80°C
ULTRA-LOW
Opdivo® and the majority of biologic comparators. Continuous monitoring, qualified shippers, excursion reporting.
PRODUCT DETAIL
Presentations we supply
100 mg/4 mL vial
Legacy
Form
Powder for concentrate for solution for infusion
Pack
Single Lyophilised vial × 1
Storage
2–8 °C, protect from light
Markets
Global
Typical lead time
On enquiry
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 and immunology
Access to 15,000+ medicines
Warehousing and distribution across 60 countries
GDP-compliant cold chain at every temperature
Full regulatory documentation with every shipment
Documentation
Batch-specific analytical results confirming the product meets its registered specification. Supplied for every batch, in the language your regulatory submission requires
A signed declaration that the product is genuine and was acquired through the licensed supply chain, with the purchase route documented. This is the assurance against falsified or diverted product when a comparator is bought on the open market.
A signed declaration that the product is genuine and was acquired through the licensed supply chain, with the purchase route documented. This is the assurance against falsified or diverted product when a comparator is bought on the open market.
Monitoring data for every shipment, with any deviation from the required range logged, reported and assessed for impact on product quality. You receive the record whether or not an excursion occurs.
A documented record of every party that held the product between the source market and your investigator site, with dates and handover points. What you need to evidence an unbroken, traceable route at inspection.
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
A sample from each batch had to be tested before purchasing the bulk.
Solution
We hunted specific batches in European markets where batch visibility was possible.
Result
The product was delivered in full and the client’s trial never ran dry.
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.
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 receipt 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. Where a study is at risk, CSI has compressed sourcing timelines by working directly with manufacturers.
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 a validated 2-8 °C with continuous temperature monitoring, through GDP-compliant depots in 60+ countries. CSI also manages -20 °C and -80 °C requirements for other components of your study.
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