Why sourcing comparator drugs for oncology is uniquely challenging Oncology is one of the most demanding therapeutic areas for clinical trial supply. Most new cancer drugs are now tested against the existing standard of care, which means almost every oncology study needs reliable comparator drug sourcing. Many of these comparators are high-value biologics that are expensive, in tight supply, and difficult to ship, so a single sourcing gap can put an entire trial behind schedule. Clinical Services International (CSI) has delivered oncology products to more than 1,200 studies, from generics to the most sophisticated cold chain biologics, supplying medicines to clinical trials across phases I to III. That depth matters in oncology, where protocols, products and timelines are rarely simple. The oncology comparators sponsors most often need CSI’s most frequently supplied oncology comparators include pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), bevacizumab (Avastin), ipilimumab (Yervoy), nab-paclitaxel (Abraxane), palbociclib (Ibrance), rituximab (Mabthera), regorafenib (Stivarga), ruxolitinib (Jakavi), and talazoparib (Talzenna). Sourcing branded oncology products like these requires direct relationships with manufacturers and authorized distributors so that authenticity, traceability and chain of custody are never in question. The CSI clinical trial supply services are built to secure these products on time and at a competitive price. Biologics and cold chain: handling temperature-sensitive oncology drugs A large share of oncology comparators are biologics that must stay within strict temperature limits. CSI provides end-to-end cold and ultra-cold chain logistics at 2 to 8C, -20C, and -80C, using GDP-compliant processes, validated packaging, and qualified couriers, with real-time temperature monitoring and data logging. This temperature-controlled distribution protects product integrity from pickup to the trial site, which is essential when a single excursion can compromise a high-value oncology shipment. Comedications and combination therapies in oncology The standard of care in oncology is increasingly a combination of drugs rather than a single agent. Comedications and combination therapies add suppliers, logistics, and timing risk, because each product may need a different source and shipping route. CSI’s scientific team advises on the optimal sourcing strategy for every comedication a protocol requires, factoring in origin of supply, price, expiry and shipment timing, so combination regimens reach sites complete and on schedule. Biosimilars and generics: balancing cost and protocol fit Oncology sourcing is not only about branded originators. Where a protocol allows, biosimilars and generics can reduce cost without compromising the study, and CSI can advise on when these are appropriate and how to source them compliantly. The goal is always the same: the right product for the protocol, with the documentation to prove it. The CSI quality and regulatory team certifies products for release and provides the documentation that import, export, and regulators require. When supply is at risk: rescue sourcing for oncology trials Even well-planned oncology studies can face shortages, expiring batches, or sudden changes in demand. CSI supports rescue studies where sourcing, compliance, or timelines have gone wrong, and has sourced rescue medications such as ruxolitinib for global studies. A partner that plans for these risks in advance, and can act fast when they appear, protects both the budget and the patients who depend on the trial. You can review related examples in CSI’s oncology case studies. How to get started Sourcing oncology comparators well protects your timeline, your budget, and your data. To discuss comparator sourcing for an oncology study with CSI’s scientific team, contact CSI to start the conversation. Key Takeaways and FAQ In short, sourcing comparator drugs for oncology trials means handling high-value biologics, cold chain, comedications, and supply risk. A partner with deep oncology experience protects timelines and data. The questions below cover the essentials. Why is sourcing comparator drugs for oncology trials so difficult? Most oncology trials test against the standard of care, so they need branded comparators that are often high-value biologics. These products are expensive, in tight supply, and temperature-sensitive, which makes timely and compliant sourcing critical. Which oncology comparators does CSI commonly supply? Frequently supplied oncology comparators include pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), bevacizumab (Avastin), ipilimumab (Yervoy), nab-paclitaxel (Abraxane), palbociclib (Ibrance), rituximab (Mabthera), regorafenib (Stivarga), ruxolitinib (Jakavi), and talazoparib (Talzenna). How are temperature-sensitive oncology biologics handled? CSI uses end-to-end cold and ultra-cold chain logistics at 2 to 8C, -20C, and -80C, with GDP-compliant processes, validated packaging, qualified couriers, and real-time temperature monitoring and data logging.

What direct-to-patient distribution means for decentralized trials Direct-to-patient (DTP) distribution delivers investigational products straight to a participant’s home, which is what makes decentralized and hybrid clinical trials possible. Instead of asking every patient to travel to a site, a clinical trial supply partner coordinates compliant, temperature-controlled delivery to the door. For sponsors running studies in rare diseases or across dispersed populations, DTP can be the difference between slow enrollment and a trial that keeps to its timeline. Clinical Services International (CSI) supports DTP as part of its end-to-end supply services, combining sourcing, storage and distribution so a decentralized study runs from one coordinated supply chain rather than several disconnected vendors. The four direct-to-patient models There is no single way to run DTP, so CSI offers four flexible direct-to-patient services and helps sponsors match one to their protocol: Clinical Site-to-Patient ships the investigational product from the main or sub depot to the patient’s home, with home nurse services added when needed. Depot-to-Patient delivers from a GMP depot directly to the patient and is well suited to temperature-sensitive products. Pharmacy-to-Patient delivers from a central pharmacy to the patient, again with strong temperature control. The Hybrid option sends products from a site depot or central pharmacy to a home nurse, who then hands them to the patient during a home visit. When direct-to-patient is the right choice DTP is most valuable when patients are hard to reach or few in number. It is well suited to trials involving a rare disease, an orphan indication, or a geographically dispersed patient population, where every additional site visit risks dropout. If your study struggles with recruitment or retention, a DTP or hybrid model can widen the pool of eligible participants and keep them engaged through to the end. Benefits: timelines, quality, cost, and retention Adopted well, DTP can decrease timelines, improve quality, reduce costs, and help enroll and retain more patients. Bringing the trial to the patient reduces the burden of participation, which supports both recruitment and the data quality that comes from keeping participants in the study rather than losing them to travel and scheduling. Challenges to plan for: complexity and compliance DTP also adds moving parts. The main challenges are process complexity and ensuring GMP compliance at every handoff between depot, courier, nurse, and patient. Each model has to protect the chain of custody and the product’s condition, which is why careful planning matters as much as the delivery itself. How a supply partner keeps DTP compliant and cold Temperature control is central to DTP because many investigational products are biologics or other cold-chain medicines. CSI provides end-to-end cold and ultra-cold chain logistics at 2 to 8C, -20C, and -80C, using GDP-compliant processes, validated packaging, and qualified couriers, with real-time temperature monitoring and data logging, supported by a global depot network across 60 countries and six continents. This sits within CSI’s wider storage and distribution service and is backed by an independent quality and regulatory team that keeps each shipment compliant across regions. How to get started A well-designed direct-to-patient strategy can unlock enrollment, protect quality, and keep a decentralized study on schedule. To map a DTP or hybrid model to your trial, contact CSI to discuss your requirements. Key Takeaways and FAQ In short, direct-to-patient distribution makes decentralized trials possible by delivering investigational products to participants' homes. Choosing the right DTP model, and planning for compliance and cold chain, keeps a study on schedule. The questions below cover the essentials. What is direct-to-patient distribution in clinical trials? Direct-to-patient (DTP) distribution delivers investigational products straight to a participant’s home, which enables decentralized and hybrid trials. It reduces the need for site visits and is especially useful for rare disease, orphan indication, or geographically dispersed studies. What are the direct-to-patient models? CSI offers four models: Clinical Site-to-Patient, Depot-to-Patient, Pharmacy-to-Patient, and Hybrid. They differ in where the product ships from and whether a home nurse is involved, and each is designed to protect temperature control and compliance. How is temperature control maintained in direct-to-patient delivery? CSI uses end-to-end cold and ultra-cold chain logistics at 2 to 8C, -20C, and -80C, with GDP-compliant processes, validated packaging, qualified couriers, and real-time temperature monitoring and data logging.

What comparator drug sourcing involves and why it sits on the critical path Comparator drugs are needed in almost every clinical study, yet they are increasingly expensive and hard to find. Choosing the right comparator drug sourcing partner is one of the most important supply decisions a sponsor makes, because a delay or shortage on the critical path can stall an entire trial. A strong partner takes a scientific approach, reading the protocol first and then building a strategy that keeps every site supplied on time and at a competitive price. Clinical Services International (CSI) is a global leader in the clinical trial supply industry, with a team that has over 300 years of combined scientific expertise. CSI has supplied medicines to more than 1,200 clinical trials across phases 1 to 3, the kind of track record sponsors should look for when comparing partners. The six drivers of effective comparator sourcing A reliable partner should be able to explain how it manages all the factors that decide whether a comparator arrives on time. CSI frames this as six drivers: protocol interpretation, product access, supply continuity, cost control, speed, and supporting documents. Use these as your own evaluation checklist. Ask how a prospective partner interprets your protocol, how broad its product access is, and how it protects supply continuity when a product becomes scarce. The full range of CSI clinical trial supply services is built around these drivers. Sourcing strategy: country-specific, global or hybrid Every study is different, so a partner should offer more than one route to supply. CSI delivers bespoke sourcing solutions that can be country-specific, global or hybrid, drawing on a global network of qualified suppliers, manufacturers and wholesalers. A wide supplier base matters because it minimizes risk and makes it possible to source specific batches when a protocol calls for them. When you compare partners, look for one that works directly with manufacturers and authorized distributors so authenticity and traceability are never in question. Handling complexity: comedications, combination therapies and biologics Modern trials rarely involve a single product. The standard of care for many indications, especially in oncology, is now a combination of drugs, and comedications add suppliers, logistics and timing risk. Many comparators are also biologic medicines, which are harder to produce and distribute. A capable partner can advise on the optimal strategy for every comedication and combination therapy a protocol requires, factoring in origin of supply, price, logistics and shipment timing. CSI applies its comparator sourcing expertise to exactly these situations. When a trial needs rescuing: supply continuity and risk management Ask how a partner responds when a study is already in trouble. CSI supports rescue studies where procurement, sourcing, compliance, quality or timelines have gone wrong, and has sourced rescue medications such as infliximab, pembrolizumab, salbutamol, ruxolitinib, and mycophenolate mofetil for global studies, where an original partner has let them down. A partner that plans for fast or slow recruitment, expiring batches, drug shortages, and price fluctuations before they happen is far more valuable than one that only reacts after a problem appears. Documentation and quality you should expect Comparator sourcing is only as good as the documentation behind it. A partner should deliver products certified, with full quality and regulatory support, including Certificates of Analysis, Batch Release Certificates and Statements of Authenticity where required. Every investigational medicinal product must be certified by a Qualified Person before release, so ensure your partner has the capacity to do this n house. Dependable storage and distribution with full traceability from pickup to delivery completes the picture. How to get started The right comparator sourcing partner reduces complexity, protects your timeline, and controls cost from protocol analysis through final delivery. To discuss your study’s sourcing requirements with CSI’s scientific team, contact CSI to start the conversation. Key Takeaways and FAQ In short, the right comparator drug sourcing partner protects your timeline, budget and data from protocol analysis through final delivery. Evaluate partners on the six sourcing drivers, their strategy options, and how they handle complexity and supply risk. The questions below cover the essentials. What is comparator drug sourcing? Comparator drug sourcing is the procurement of the existing medicines a clinical trial tests against, including branded products, generics, and biologics, along with the documentation that proves their authenticity. Comparators sit on the critical path of almost every study, so timely and compliant sourcing is essential. How do I choose a comparator sourcing partner? Evaluate partners against the six drivers of effective sourcing: protocol interpretation, product access, supply continuity, cost control, speed, and supporting documents. Look for direct relationships with manufacturers and authorized distributors, bespoke country-specific, global, or hybrid strategies, and proven experience with complex and rescue studies. What documentation should a comparator sourcing partner provide? Products should be delivered certified, with Certificates of Analysis, Batch Release Certificates, and Statements of Authenticity where required, and every investigational medicinal product should be certified by a Qualified Person before release.

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We discuss the importance of comparator medicines in Arena International's 2023 Outsourcing in Clinical Trials handbook Our article entitled ‘Budgeting for Clinical Trials: The Importance of Comparator Medicines’ appears in the 2023 Outsourcing in Clinical Trials (OCT) handbook by Arena International. Due to the growing number of global trials, and their increasing complexity, as well as drug shortages becoming more prevalent, sourcing comparator drugs has become more difficult.  With over 25 years of experience supplying clinical trials, we have gained a deep understanding of the availability of comparator drugs across the globe and what considerations organisations should take when creating their clinical trial budget.   The OCT handbook is the go-to guide for professionals in the global clinical outsourcing space, with insights from leading industry experts, including Clinical Services International (CSI). Read our feature here What we highlight  General considerations when preparing a clinical trial budget  Ethical considerations and competition among clinical trials driving comparator demand Factors to consider when building your comparator sourcing budget Risk mitigation in comparator sourcing As the article explains, budgeting for comparator drugs isn’t a simple process, with numerous potential pitfalls. As a result, having a comparator drugs supplier who can overcome these challenges is essential. With our network of over 95 manufacturers across more than 50 countries and six continents, CSI can optimise your comparator sourcing strategy and ensure that high-quality, on-time, and on-budget comparator drugs are delivered to your clinical trial. If you enjoyed reading our article and want to discuss your clinical trial requirements with CSI, please  contact us  today.

How CSI leveraged its vendor and warehouse networks to supply aflibercept for an Ophthalmology study within a tight deadline Challenge CSI was tasked with sourcing 400 packs of aflibercept from the open market within a tight deadline of two-to-three weeks. A strict expiry date for the product was specified by the client, and the challenge was greater than usual as the order was placed during the Christmas period, which meant warehouse closures and delayed response times from suppliers. To make matters more complex, the client requested a change in quantities after the initial order, resulting in split deliveries that risked further extending the timescale. Solution Despite these obstacles, CSI successfully leveraged its relationship with a local vendor to secure the required quantity. Effective communication and coordination between CSI, the client, the vendor and CSI’s warehouse were key during the disrupted holiday period and ensured smooth delivery and completion of quality control checks. Result The required quantity of aflibercept was successfully delivered to CSI’s warehouse for immediate distribution to hospitals. True to our promise that no patient would be turned away for lack of medication, the ophthalmology product was delivered within the specified timeframe to several hospitals in the United States.

How CSI supplied large quantities of ruxolitinib to a biotech’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Challenge CSI was approached by a biotech conducting a full global Phase 3 oncology study spanning 14 countries. We were asked to purchase and supply a significant quantity of ruxolitinib within a tight timeframe: with the contract signed in December 2022, the client aimed to have the first sites supplied by March 2023. The client also required three annual resupplies of the oncology medicine to be factored into the request. Solution Within eight weeks, the entire study setup had been meticulously organised, ensuring the smooth and timely execution of the clinical trial supply chain. CSI’s strong relationships with manufacturers around the world and outstanding access to oncology products allowed for the procurement of a substantial volume of ruxolitinib within a short timeframe. CSI’s global depot network facilitated the efficient delivery of the oncology medication without delay – just in time for the client’s tight deadline. Result CSI’s scientific expertise ensured a seamless and smart study setup, with all aspects of the trial addressed meticulously in the supply planning phase. Despite the challenge of working to a tight deadline and the logistical complexities involved in coordinating product supply across 14 countries, nine depots and 67 individual site shipments, CSI successfully delivered a large quantity of the required oncology medicine in line with the client’s needs and expectations. This, in turn, allowed for Site Initiation Visits (SIVs), which had already been scheduled, to take place as planned, keeping the client’s study on track.

CSI is extremely proud to announce our Platinum EcoVadis Award, signifying the highest level of recognition for corporate sustainability performance. This prestigious certificate is awarded to companies that demonstrate outstanding sustainability practices across environmental, social, and ethical governance. Achieving the Ecovadis Platinum award confirms that CSI has excelled in sustainability performance evaluation, surpassing industry standards. This award reflects our commitment to sustainable business practices and responsible corporate citizenship. Contact CSI, your platinum clinical trial supply partner.

CSI is proud to set up The Vanessa Dekou Scholarship for Scientists to contribute to the education of the next generation of leaders in life sciences The Vanessa Dekou Scholarship for Scientists will help finance a Cambridge MBA education for candidates with advanced degrees in scientific fields such as biological sciences, chemistry and physics. It is funded through a generous donation from Vanessa Dekou, a Cambridge Judge Business School alumna (MBA 2002) who has forged a successful career in entrepreneurship and biotech. Gishan Dissanaike, the Interim Dean of Cambridge Judge Business School adds: We are very grateful to Vanessa Dekou for establishing this wonderful scholarship in her name to help fund a Cambridge MBA education for students with a scientific background. Cambridge Judge is proud to integrate vital areas such as healthcare, climate change and technology into our Business School curriculum and activities, so this scholarship will help us to attract people with diverse backgrounds in science who can use their Cambridge Judge experience to advance scientific knowledge. Vanessa Dekou says: When I arrived at the UK in September 1991 as an undergraduate, I had big dreams about my future. I educated myself to PhD/MBA level and through my education, perseverance and incredible hard work I managed to build CSI from scratch; to contribute to advances in healthcare and create employment and prosperity. I am thrilled and humbled that through Cambridge Judge Business School I am in the fortunate position to give back to our society and inspire other scientists to innovate and progress. The Scholarship will be awarded based on academic excellence, and while there is no fixed deadline early application is recommended.

How CSI’s flexible approach to global distribution ensured a large biotech’s three-year study across 15 countries could proceed without delay Challenge CSI was tasked with providing crucial support to a large biotechnology company in distributing medical devices for a three-year study spanning 15 countries in Europe (EU), the United States (US) and Asia-Pacific (APAC). A central sourcing approach was not suitable for the client due to import and export complications, as well as the high VAT of the required product. It was a particular challenge to find 15 warehouses that were able to accommodate the storage of the required medical devices within a short timeframe since they contained lithium batteries, which are classed as dangerous goods. The majority of GMP warehouses are limited to the storage of medication, which made qualification all the more complex. Solution After conducting a rigorous search and leveraging our networks, CSI identified suitable partner warehouses, auditing and qualifying them within the rapid timeframe required for the client’s study to progress without delay. Result With CSI’s outstanding supply chain solutions and expertise in import and export, we provided stock to all depots and sites across the world. We also managed the return of all devices, creating country-specific return kits for each location. CSI’s flexible approach to ancillary sourcing ensured we were able to supply all sites before the Site Initiation Visit (SIV), enabling the client’s study to commence on time.

Ancillaries play a crucial role in ensuring the smooth execution of clinical trials, encompassing a broad range of items, materials and services beyond the investigational product itself. From medical and wearable devices and diagnostic tools to specialized equipment, ancillaries are indispensable components of the clinical trial supply chain. What are Ancillaries? Ancillaries refer to any supplementary items or services required for the proper functioning of a clinical trial beyond the primary investigational product. These can include: Medical Devices: Such as infusion pumps, wearable sensors, or monitoring devices necessary for patient care and data collection. Diagnostic Tools: Including imaging modalities, laboratory assays and diagnostic kits utilised for patient assessment and disease monitoring. Clinical Supplies: Such as bandages, swabs, and other medical consumables, simple but essential for trial procedures. The Importance of Ancillaries in Clinical Trials Ancillaries are integral to the successful execution of clinical trials for several reasons: Patient Safety: Many ancillaries directly contribute to patient safety during the trial by providing essential medical care and monitoring. Data Quality: Ancillaries often facilitate data collection, allowing researchers to gather accurate and reliable information crucial for evaluating the safety and efficacy of investigational products. Regulatory Compliance: Compliance with regulatory requirements is paramount in clinical research and ancillaries often play a key role in meeting these standards through proper documentation and adherence to guidelines. Sourcing Ancillaries for Clinical Trials Clinical Services International (CSI) offers comprehensive solutions for sourcing ancillaries alongside comparator drug supply. Leveraging a vast network of trusted suppliers and strategic partnerships, CSI ensures the timely procurement and delivery of ancillary items and services tailored to the unique requirements of each study. Supplier Network: CSI maintains a robust network of qualified suppliers, specialising in various ancillary categories, ensuring access to a diverse range of products and services to meet trial needs. Tailored Solutions: Understanding that each clinical trial is unique, CSI works closely with our clients to develop customized sourcing strategies aligned with study protocols. Quality Assurance: CSI prioritises quality and compliance, partnering with reputable suppliers and conducting rigorous quality assessments to ensure that all ancillary items meet regulatory standards. Logistical Expertise: With extensive experience in clinical trial logistics, CSI offers end-to-end supply chain management services, including warehousing, distribution, and inventory management, to ensure seamless delivery of ancillary items to clinical sites worldwide. By partnering with a trusted provider like CSI, our clients can access a comprehensive range of ancillary solutions tailored to their specific research needs, thereby enhancing the success of their clinical trials. We minimise wastage and administration from the sponsor, lower the number of invoices to process, complete the oversight of study requirements and reduce human capital investment from our sponsors.

CSI managing complex adaptive supply chain of a respiratory study in 22 countries Request CSI received a request from a Blue Chip, listed, industry-leading Pharma to locally source for a respiratory study spanning 22 countries across the EU, North America, and South America. The study involved a vast number of 80 sites but also required sourcing 3-4 different products in each country. Challenge The study duration spanned over three years however all products had a 2-year shelf life, which meant more than 1 purchase was required. To add further complexity to the study requirements, each country had different drug presentations and strengths available, necessitating an investigation into what was marketed locally. CSI had to set up and manage 22 different local depots, within a short space of time to meet the first patient SIV. To make matters more challenging, the sponsor frequently revised the quantities due to changing patient and site numbers, as well as adjustments to the country list and study protocol, with a very tight timeline. Solution CSI worked tirelessly to rapidly adapt to the frequent and last-minute revisions made by the sponsor, effectively accommodating all requirements to ensure seamless execution. To overcome the varying product shelf-life, CSI proactively split the product purchasing into three phases to ensure all products remained valid until the study's end. By leveraging CSI’s unmatched local expertise and market knowledge, CSI successfully supported the challenging product supply, enabling the study to reach successful completion within budget.