Global Keytruda® Comparator Sourcing
CSI has extensive experience purchasing Keytruda®, supplying the medicine to hundreds of 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 Keytruda® (pembrolizumab), CSI understands that it is commonly supplied alongside complementary oncology therapies, including Carboplatin, Paclitaxel, Cisplatin, Pemetrexed and Gemcitabine. 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.
Keytruda® (pembrolizumab) Comparator Sourcing
The clinical supply partner of choice
CSI's scientific team builds the sourcing strategy around your protocol: which presentations the sites require, which markets can supply them, factoring in export bans, and how far ahead the volume has to be secured to account for the expiry. Every unit arrives with the documentation your QP and regulatory teams expect, sourced through qualified manufacturers and wholesalers inside a fully traceable chain.
We provide:
Global sourcing
Europe, North America, Latin America and Asia-Pacific, through 200+ qualified manufacturers and suppliers.
Vial and pack formats matched to protocol and site requirements across every participating market.
Temperature-controlled logistics
GDP-compliant cold chain at 2 to 8°C, monitored continuously from source to site.
Supporting documentation
Certificates of Analysis, Batch Release Certificates and Statements of Authenticity upon request.
Forecasting for long-term programmes
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
100 mg / 4 mL
Single pack
Form
Pack
Storage
Markets
Concentrate for solution for infusion
Single-use vial × 1
2–8°C, protect from light
EU · US · LATAM · APAC
100 mg / 4 mL
Double pack
Form
Pack
Storage
Markets
Concentrate for solution for infusion
Single-use vials × 2
2–8°C, protect from light
EU · US · LATAM · APAC
COLD CHAIN
CSI supports all temperature requirements
Pembrolizumab 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
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.
Challenge
A sample from each batch had to be tested before purchasing the bulk.
Result
The product was delivered in full and the client’s trial never ran dry.
Challenge
A sample from each batch had to be tested before purchasing the bulk.
APPLICATIONS
Where sponsors use Keytruda® 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
Keytruda® sourcing, answered
Can CSI supply pembrolizumab (Keytruda®) as a comparator for a global study?
Yes. CSI is a large purchaser of Keytruda® and supplies pembrolizumab to 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 pembrolizumab are available?
Price, expiry and availability are confirmed prior to the receipt of a Purchase Order.
How long does comparator sourcing for pembrolizumab 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’ll assess what’s possible for your programme. What have you got to lose? Where a study is at risk, CSI has successfully compressed sourcing timelines by working directly with manufacturers — our case studies show how.
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 pembrolizumab?
Pembrolizumab is shipped in 2–8 °C with continuous temperature monitoring, through GDP-compliant depots in 61 countries.
Can CSI supply other medicines alongside pembrolizumab?
As an expert supplier of Keytruda® (pembrolizumab), CSI understands that it is commonly supplied alongside complementary oncology therapies, including Carboplatin, Paclitaxel, Cisplatin, Pemetrexed and Gemcitabine. 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.
Send us the protocol, the destination and the timeline. Our scientific team will come back with a sourcing strategy for your Keytruda® requirements.
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