Global Venetoclax comparator supply for oncology clinical trials
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.
Venclyxto® (venetoclax) Comparator Sourcing
The clinical supply partner of choice
venetoclax 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 Venclyxto® order gets from CSI
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.
COLD CHAIN
Three temperature regimes, one validated
venetoclax 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
Venclyxto® and the majority of biologic comparators. Continuous monitoring, qualified shippers, excursion reporting.
−20°C
FROZEN
Venclyxto® and the majority of biologic comparators. Continuous monitoring, qualified shippers, excursion reporting.
−80°C
ULTRA-LOW
Venclyxto® 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 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 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 60+ countries and manages 2-8 °C, -20 °C and -80 °C alongside it.
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