Global Venetoclax Comparator Supply
CSI has significant experience sourcing Venetoclax for oncology clinical trials worldwide. Frequently used in combination with Azacitidine for the treatment of acute myeloid leukaemia (AML), our team can source both medicines as part of a coordinated comparator supply strategy, simplifying procurement and ensuring continuity throughout your study.
With extensive experience supporting complex oncology programmes, CSI works closely with sponsors to secure authenticated comparator medicines, manage global logistics and provide the regulatory documentation required for multinational clinical trials.
Venclyxto® (venetoclax) Comparator Sourcing
The clinical supply partner of choice
Venetoclax is widely used across AML and haematology programmes, in combination with azacitidine. For sponsors running multi-country studies, maintaining a consistent supply across regions is essential, not simply fulfilling a single order.
CSI’s scientific team develops the sourcing strategy around your protocol, identifying the presentations sites require, the markets that can supply them compliantly, and how far in advance volumes need to be secured. This approach helps minimise delays and maintain continuity of supply, even when availability becomes more challenging.
Every unit arrives with the documentation your QP and regulatory teams expect, sourced through qualified manufacturers and wholesalers within a fully traceable supply chain.
We provide:
Global sourcing of Venetoclax and Azacitidine
Both products sourced together as a single coordinated comparator supply.
Coordinated supply for combination therapy studies
Aligned delivery so neither arm of the combination waits on the other.
Manufacturer and market sourcing strategies
Routes selected per market to protect continuity across a long programme.
Temperature-controlled global distribution
GDP-compliant cold chain with continuous monitoring and excursion reporting.
Certificates of Analysis and supporting regulatory documentation
Batch-specific documentation supplied with every shipment.
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
10 mg
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10 tablets
5 blisters × 2 tablets
10 mg
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14 tablets
7 blisters × 2 tablets
50 mg
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5 tablets
5 blisters × 1 tablet
50 mg
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7 tablets
7 blisters × 1 tablet
100 mg
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7 tablets
7 blisters × 1 tablet
100 mg
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14 tablets
7 blisters × 2 tablets
100 mg
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112 tablets
4 × 28 tablets
100 mg
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360 tablets
3 bottles × 120 tablets
COLD CHAIN
CSI supports all temperature requirements
Venetoclax is an oral solid dose and ships under controlled ambient conditions with temperature monitored in transit. Where a protocol also requires refrigerated or frozen product, CSI validates the full range so combination and concomitant supply moves 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
Accelerating Global AML Study: How CSI Streamlined Venetoclax and Azacitidine Supply Across 17 Countries in Record Time
Also read: CSI Partners with Ryvu to Deliver Comparator Supply for a Global Oncology Study
Also read: CSI Partners with Ryvu to Deliver Comparator Supply for a Global Oncology Study
Request
CSI was entrusted with sourcing large quantities of Venetoclax and Azacitidine for a study spanning 17 countries and three continents
Challenge
The client faced a tight six-month enrollment deadline and required Certificates of Analysis (CoA) for a complex study
Solution
CSI utilized its partnerships to halve approval times, reduce supply lead times from four months to four weeks and ensure timely delivery with all required documentation
APPLICATIONS
Where sponsors use Venclyxto® 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
Venclyxto® sourcing, answered
Can CSI supply venetoclax as a comparator for a global study?
Yes. CSI sources Venclyxto® (venetoclax) 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.
Can venetoclax and azacitidine be supplied together?
Yes. Venetoclax is frequently used with azacitidine in acute myeloid leukaemia. CSI can source both as a single coordinated comparator supply, so neither arm of the combination waits on the other.
How long does comparator sourcing for venetoclax 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 venetoclax stored and shipped?
Venetoclax is an oral solid dose and ships under controlled ambient conditions (15-25 C) with temperature monitored in transit, rather than on a 2-8 °C cold chain. Where a protocol also requires refrigerated or frozen product, CSI operates GDP-compliant depots in 61 countries and manages 2-8 °C, -20 °C and -80 °C alongside it.
Send us the protocol, the markets and the timeline. Our scientific team will come back with a sourcing strategy for your Venclyxto® and Azacitidine requirements.
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