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.

CSI case studies show how we deliver global clinical trial supplies - comparators, devices, and ancillaries - on time, in budget, and fully compliant Case Studies CSI’s expertise in drug development means we can provide innovative solutions to supply global clinical trials, however complex. Learn how we do this below. At CSI we accelerate drug development by designing and delivering highly efficient and robust supply chains that allow our partners to deliver their clinical trials on time and budget. Filter: Therapeutic Area/Phase Select to filter: Supply Challenge/Characteristics Select to filter: Comparator Product Select to filter: Effective Sourcing of Semaglutide for a Global Phase III Clinical Trial Ensuring batch-consistent, compliant comparator supply across NA, EU, and APAC - on time and uninterrupted. Read More CSI's 72-hour Abraxane Rescue Mission From supply shortfall to on-time first-patient-first-visit across Europe, delivered in three days. Read More CSI’s Expert Delivery of a Global Respiratory Study Adaptive, multi-product supply across 22 countries and 80 sites, kept on time, in budget and compliant. Read More Rapid Sourcing of Discontinued Southern Hemisphere Vaccine for a Global Biopharmaceutical Client A leading global biopharmaceutical company urgently requested CSI to supply the Fluarix QIV Southern Hemisphere Vaccine for 2025. Read More Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies Securing reliable, cost-effective, long-term supply of Eylea PFS from EU and USA for a global biotech company’s clinical studies. Read More Comparator Sourcing for a Phase II Ophthalmology Study A biotech client asked CSI to source Lucentis for a Phase II ophthalmology trial. Read More How CSI streamlined Venetoclax and Azacitidine supply across 17 countries in record time CSI Efficiently Delivered Venetoclax and Azacitidine Across 17 Countries Read More CSI’s seamless comparator export to China Export of expensive comparators from Europe to China with first leg documents and streamlined approach Read More Global Device Distribution CSI’s flexible approach to global distribution ensured a large CRO's five-year and three-year studies across a total of 18 countries could proceed without delay Read More Rescuing a Global CRO's Oncology Study with Cetuximab How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Read More Delivering €1 million Savings for Pembrolizumab How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price Read More Global CRO Oncology Partnership How CSI supplied large quantities of Jakavi to a Biotech’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read More A Quality Solution to Clinical Trial Supply How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial Read More Oncology Product Batch Hunting How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read More Delivering Comparators for a Global Allergy Study How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries Read More Sourcing Flu Vaccines for a Global Trial How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule Read More Rapid Eylea Study Supply How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s study within a tight deadline Read More Streamlining a Biotech's Supply Chain with local sourcing How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read More Overcoming Drug Shortages How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read More found 19 results Golf

Clinical Services International’s (CSI) China operations support clinical trials across China and APAC with local sourcing, regulatory insight, compliant distribution and global supply expertise. China Operations Supporting Clinical Trials Across China, APAC and Beyond At Clinical Services International (CSI), our China operations play a critical role in supporting global clinical trials with regional expertise, regulatory insight, and established supply networks across Asia-Pacific. With a presence in China and strong regional partnerships, we enable smart sourcing, compliant distribution and seamless integration into global clinical supply strategies. Shanghai China Presence: Local Access, Regional Strength Our China team operates at the centre of one of the world’s fastest-growing clinical trial markets, supporting both local and global sponsors. From China, we provide: Direct access to regional manufacturers and distributors Strong connectivity across APAC markets including Japan, South Korea, Singapore, and Australia On-the-ground expertise to navigate complex import/export requirements As part of CSI’s global infrastructure, our China operations are fully integrated with our teams across the USA, Europe and beyond, ensuring consistent execution across multinational trials. Our Local Team Dr. Chenguang Li Hayley Zhai Global Reach, Local Expertise CSI supports clinical studies in over 60 countries across six continents, combining global scale with local execution. From China, we: Support Asia-Pacific trial sites with faster regional access Enable cross-border supply into North America, Europe, and emerging markets Accelerate the drug development of clients based in USA and Europe that wish to perform studies in China with local sourcing Ensure compliance with global and local regulatory frameworks What We Do in China Whether you are running a local Phase I study in China or managing a global Phase III trial with APAC sites, CSI ensures consistent, reliable, and compliant delivery of clinical supplies. Comparator Sourcing Direct access to regional and global manufacturers Sourcing across innovative, branded, and hard-to-access medicines Storage and Distribution Temperature-controlled logistics across APAC Secure and compliant cross-border shipment management Project Management China-based experts with global coordination Alignment of regional supply with global study timelines Direct-to-Site & Depot Shipments Efficient delivery to clinical sites across China and APAC Full traceability and documentation throughout the supply chain Our Services APAC Connectivity CSI’s China operations act as a gateway to Asia-Pacific, enabling: Rapid access to key APAC markets Strong regional logistics partnerships Flexible supply strategies for multi-country trials Our established supplier network ensures we can deliver comparator and ancillary supplies directly to sites across the region without delay. A Scientific Approach to Clinical Supply CSI brings a science-led approach to comparator sourcing and supply strategy, combining: Protocol-driven planning Risk mitigation for supply constraints Market intelligence across global and regional supply chains Our fully scientific team and global experience allow us to deliver tailored, efficient solutions that keep studies on track and reduce delays. Learn more about our services Why Sponsors Choose CSI for China & APAC Studies Reliable access to medicines across China and Asia-Pacific Integrated global + local supply chain expertise Regulatory support for import/export Temperature-controlled logistics and secure distribution Scientific and project teams with deep therapeutic knowledge Asia Pasific Our Offices China United Kingdom Germany United States Clinical Services International Ltd 50 Sloane Avenue Suite 212 London SW3 3DD United Kingdom info@csint.com +44 (0)203 954 0517 CSI Clinical Services International GmbH Hannoversche Straße 2 10115 Berlin Germany info@csint.com +49 (0)30 2843 0782 Clinical Services International LLC 795 Horsham Road Horsham PA 19044 United States info@csint.com +1 (267) 267 3993 Clinical Services International Room 1501 & 1508 699 West Nanjing Road Jing’an District Shanghai 中国上海市静安区南京西路699号 1501室 & 1508室 info@csint.com + 86 21 3100 7900 ext. 168 graph Medical equipment Technological equipment Print materials Electrocardiogram (ECG) tests Spirometers Weighing scales Blood pressure monitors Infusion pumps Cooled or uncooled centrifuges Refrigerators Visit our Sustainability page START eDiaries Mobile devices Laptops Printers Pill splitters Investigator site files Pharmacy binders Patient recruitment material Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit

How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial More case studies Ensuring batch-consistent, compliant comparator supply across NA, EU, and APAC - on time and uninterrupted. Read all Effective Sourcing of Semaglutide for a Global Phase III Clinical Trial From supply shortfall to on-time first-patient-first-visit across Europe, delivered in three days. Read all CSI's 72-hour Abraxane Rescue Mission Adaptive, multi-product supply across 22 countries and 80 sites, kept on time, in budget and compliant. Read all CSI’s Expert Delivery of a Global Respiratory Study A leading global biopharmaceutical company urgently requested CSI to supply the Fluarix QIV Southern Hemisphere Vaccine for 2025. Read all Rapid Sourcing of Discontinued Southern Hemisphere Vaccine for a Global Biopharmaceutical Client Securing reliable, cost-effective, long-term supply of Eylea PFS from EU and USA for a global biotech company’s clinical studies. Read all Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies A biotech client asked CSI to source Lucentis for a Phase II ophthalmology trial. Read all Comparator Sourcing for a Phase II Ophthalmology Study CSI Efficiently Delivered Venetoclax and Azacitidine Across 17 Countries Read all How CSI streamlined Venetoclax and Azacitidine supply across 17 countries in record time Export of expensive comparators from Europe to China with first leg documents and streamlined approach Read all CSI’s seamless comparator export to China CSI’s flexible approach to global distribution ensured a large CRO's five-year and three-year studies across a total of 18 countries could proceed without delay Read all Global Device Distribution How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Read all Rescuing a Global CRO's Oncology Study with Cetuximab How CSI fulfilled what our competitors couldn’t: rapidly sourcing oncology medication from the EU for a trial in South Korea Read all Rescuing a Global CRO's Oncology Trial with Lenvima How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price Read all Delivering €1 million Savings for Pembrolizumab Challenge ----- ------ ---- --P1-----forRichtext------------ Solution ----- ------ ---- --P1-----forRichtext------------ Result ----- ------ ---- --P1-----forRichtext------------ Case Study --- --- ---fORTitle --- --- ---- --- ----- ------ ----- ------- -- -- ------ - -forSubtitle --- ----- -- ------ ----- ------- -- -- --------- Challenge To help a leading biotech's transition from a central to a local sourcing model for ancillary products for a global clinical trial Solution CSI provided the client with all available products in the trial countries around the world for compatibility testing with their investigational product Result The client migrated to a local site sourcing model, creating a much simpler, more efficient, agile and cost-effective supply chain Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit