Key takeaways • A clinical trial rescue stabilizes a study whose supply chain is failing or at risk mid study. • Common triggers: a supplier that cannot deliver, a comparator or IMP shortage, a lot or expiry problem, or a partner exit. • Two clocks run at once: patients need doses on schedule, and every unit still needs full compliance documentation. • A rescue partner brings global sourcing reach, regulatory handling, and cold chain continuity under time pressure. • Planning for rescue scenarios early reduces the impact if something goes wrong. When a trial supply chain falters mid study, dosing schedules, data integrity and patient safety are all on the line at the same time. A clinical trial rescue is the work of stabilizing that situation quickly and correctly. This guide explains what a rescue involves, what triggers one, and how a supply partner approaches it. It is the reactive counterpart to proactive clinical trial drug shortage risk management, which aims to prevent the crisis in the first place. What is a clinical trial rescue? A clinical trial rescue is the rapid recovery of a study whose supply chain is failing or at immediate risk. In practice it can mean re-sourcing a comparator or investigational medicinal product, replacing a supplier who cannot deliver, or rebuilding documentation and distribution so that patients keep receiving doses on schedule. It often overlaps with comparator drug sourcing, because a missing comparator is one of the most common reasons a study lands in trouble. Common triggers for a clinical trial rescue • A supplier or partner that cannot deliver on time, or exits the project mid study. • A comparator goes into shortage, is discontinued or becomes hard to source. • A specific lot or expiry problem that removes usable stock from the study. • A regulatory, import or customs hold that stops product at a border. • A protocol change or enrollment surge that outpaces the original supply plan. • A quality issue or temperature excursion that quarantines stock. Why speed and documentation both matter In a rescue, two clocks run at once. The clinical clock says patients need doses now. The compliance clock says every replacement unit still needs its Certificate of Analysis, Batch Release Certificate, and good distribution practice handling. Cutting corners on documentation to save days creates risk that surfaces later. Protecting both at once is exactly where quality and regulatory support earns its place. How a supply partner approaches a rescue • Rapid assessment of remaining stock, expiry dates and true remaining demand. • Global sourcing reach to locate available product and specific lots quickly. • Regulatory, import and export handling so replacement stock can move legally. • Cold chain continuity for temperature sensitive product. • Clear communication and reporting so the sponsor can make decisions fast. These capabilities are the same ones that support day to day supply through CSI's clinical trial supply services, applied under time pressure and with a narrower margin for error. Planning ahead: rescue readiness The best rescue is the one you never need. Sponsors can reduce the risk by mapping single points of failure, holding buffer stock where appropriate and lining up a sourcing partner before a crisis. Building this thinking into a comparator strategy early means that if something does go wrong, the response is a phone call rather than a scramble. Summary and FAQ A clinical trial rescue recovers a study whose supply chain is failing, by re-sourcing product, rebuilding documentation, and restoring distribution without breaking dosing continuity or compliance. The triggers are predictable, the response is faster when a partner is lined up in advance and readiness planning is the cheapest insurance a sponsor can buy. What is a clinical trial rescue? A clinical trial rescue is the rapid recovery of a study whose supply chain is failing or at immediate risk. It usually means re-sourcing a comparator or investigational product, replacing a supplier who cannot deliver, and rebuilding documentation and distribution so that dosing continues without interruption. When do sponsors need a rescue partner? Sponsors typically need a rescue when a supplier cannot deliver, when a comparator or IMP goes into shortage or is discontinued, when a specific lot or expiry problem appears, or when a supply partner exits mid study. Any of these can threaten dosing continuity. How fast can a clinical trial rescue happen? Speed depends on drug availability, the regulatory and import route, and the countries involved. The priority is to protect dosing continuity while keeping full documentation, so a realistic timeline is set once stock, demand, and sourcing options are assessed. Does a rescue compromise compliance? No. Documentation such as Certificates of Analysis and Batch Release Certificates, and good distribution practice handling, still apply. A capable partner protects compliance under time pressure rather than trading it for speed. How can sponsors reduce the risk of needing a rescue? Map single points of failure in the supply chain, hold buffer stock where it makes sense, keep documentation current, and line up a sourcing partner before a crisis rather than during one. Facing a supply chain at risk, or want to build rescue readiness into your plan? Request a consultation with CSI. Read CSI's rescue mission examples: Case Study | Rapid Sourcing of Discontinued Southern Hemisphere Vaccine for a Global Biopharmaceutical Client Rescuing a Global Biotech’s Oncology Study with Cetuximab

A recent article from Fierce Biotech highlights the world's top emerging biotech hubs for 2026, showcasing the regions attracting investment, innovation and the next generation of life sciences companies. As these biotech ecosystems continue to grow, proximity matters. With offices strategically located in London, Berlin, Philadelphia and Shanghai, Clinical Services International (CSI) is well positioned to support sponsors across many of these fast-growing life sciences hubs. London – providing direct access to the UK's thriving biotech sector. Berlin – supporting Germany's rapidly expanding life sciences market and wider Central Europe. Philadelphia (Horsham, PA) – approximately 45 minutes from Philadelphia's biotech cluster, around 2 hours by road from New York City, and approximately 1 hour 20 minutes by air from Boston. Shanghai – around 30–40 minutes by high-speed rail from Suzhou BioBay, approximately 1 hour by high-speed rail from Hangzhou, and around 2 hours 20 minutes by air from Beijing. Whether sourcing comparators, managing global clinical trial supplies or supporting complex international studies, having experienced teams close to leading biotech ecosystems enables faster communication, stronger supplier relationships and more agile project delivery. As the global biotech landscape continues to evolve, CSI is already positioned to support many of the world's most exciting and innovative biotech communities.

Clinical Services International (CSI) is proud to reaffirm its commitment to the United Nations Global Compact (UNGC) following the successful submission of our 2025 Communication on Progress (CoP). As a participant in the world's largest corporate sustainability initiative, CSI continues to align its business operations with the Ten Principles of the UN Global Compact, covering human rights, labour, environmental responsibility and anti-corruption. Embedding Responsible Business Practices At CSI, sustainability extends beyond compliance. It influences how we operate across our global clinical trial supply chain, from responsible sourcing and ethical procurement to building trusted partnerships with manufacturers, suppliers and clients worldwide. As a specialist in comparator sourcing and clinical trial supply, we recognise the importance of maintaining high standards of governance while supporting pharmaceutical, biotechnology and CRO clients across global studies. Measuring Progress Each year, participants in the UN Global Compact submit a Communication on Progress (CoP), outlining the actions they have taken to implement the Ten Principles and contribute to the UN Sustainable Development Goals. The submission of our 2025 CoP demonstrates CSI's ongoing commitment to transparency, accountability and continuous improvement in our environmental, social and governance (ESG) performance. Supporting a More Sustainable Future Our participation in the UN Global Compact complements CSI's wider sustainability initiatives, including: EcoVadis Platinum rating, placing CSI among the top 1% of companies assessed globally Responsible sourcing and ethical supply chain management Strong corporate governance and compliance standards A continued focus on reducing environmental impact and supporting sustainable business practices As the clinical research industry continues to evolve, CSI remains committed to helping clients deliver global clinical trials while operating responsibly and contributing to a more sustainable future.

How CSI fulfilled what our competitors couldn’t: rapidly sourcing oncology medication from the EU for a trial in South Korea. 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 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 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 all Global Biotech Oncology Partnership Challenge A mid-sized biotechnology company running an oncology trial in South Korea required a small volume of lenvatinib with a Certificate of Analysis (CoA). They had been let down by another supplier, who was unable to find a CoA on the open market. A further challenge was the relatively low quantity of the cancer medication required, which meant that the manufacturer of the drug was reluctant to supply the company’s trial. Solution Through conducting market research and leveraging our manufacturer and supplier networks, CSI was able to provide two viable sourcing options for the desired quantity of the oncology medicine with CoAs – one from the Korean market (which would not require relabelling to be used in the client’s study) and one from the European market with CoA (which would require relabelling for the South Korean trial). Result While the manufacturer was originally reluctant to supply a small volume of lenvatinib, CSI leveraged its strong, longstanding relationships and managed to secure the supply. The client proceeded with the stock sourced from the European market with CoA, which rescued their oncology study. The delivery was handled efficiently and CSI has since become a trusted partner of the biotechnology company, who have submitted two further resupply orders within two months of the fulfilment of the original purchase order. Case Study Rescuing a Global CRO's Oncology Trial with Lenvima How CSI fulfilled what our competitors couldn’t: rapidly sourcing oncology medication from the EU for a trial in South Korea. Challenge To source Lenvima/lenvatinib for a biotechnology company’s oncology trial in South Korea where supply couldn’t keep up with demand Solution CSI presented two sourcing options for the required quantity of medication, from either the Korean or the European market Result The trial was rescued using European stock and CSI has since become a preferred supply partner for the biotech company 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 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 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 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 One of our clients, a leading T Cell Receptor (TCR) biotechnology company, has several biological therapy products in development for a range of oncology and autoimmune indications. They also conduct first-in-class research into new treatments for infectious diseases utilising their pioneering immunotherapies. The client approached CSI while running clinical trials in many different countries for an investigational product that is administered in conjunction with saline and human serum albumin (HSA). CSI was approached to evaluate and provide evidence so that our client could move from a central model to a local sourcing model for these ancillary products. There are a wide variety of saline and HSA products available in the trial countries, each with different bag or container materials. Since there was limited stability data regarding the equivalency of local products, the client initially had to source all saline and HSA centrally. This had a significant impact on costs and logistical complexity. While saline and HSA bags or containers are inexpensive, they are bulky and heavy products, so a central sourcing model increases overhead costs and adds complications and potential delays to the supply chain. In this case, the saline and HSA had to be relabelled to reflect the language of each trial country, which added yet more expense and complexity to the undertaking. Solution CSI provided scientific insight regarding the different types of bag or container materials that are marketed and used to carry saline and HSA, as well as the different strengths of HSA available across the large number of countries in the trial, including: Australia Canada France Germany New Zealand Russia Ukraine United Kingdom United States The range of products was diverse and included rigid containers and flexible bags made from a variety of materials, including polyethylene (PE), polypropylene (PP), PE/PP copolymers and blends, and polyvinylchloride (PVC). CSI sourced quantities of these products in different pack sizes and from different countries, covering the full range of materials used. Our client then carried out analytical testing to confirm the compatibility of their investigational product with each type of container material and the different strengths of HSA. Result After confirming the compatibility of their investigational product with the different saline and HSA bag or container products, our client migrated to a local site sourcing model for the saline and HSA used in their trial. This averted the need to centrally source and distribute these heavy items, creating a much simpler, more efficient, agile and cost-effective supply chain. In addition, the core product became easier to use and more attractive since no specific ancillaries were required for its administration. This resulted in very significant savings for the duration of the study. Case Study 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 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

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 More case studies 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 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 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 CSI was approached to support a quadrivalent influenza vaccine study running in multiple countries in the Northern Hemisphere. The sponsor wanted to use the same product across all participating countries in the trial. Due to the seasonal nature of this vaccine, there is only one production run per year, which takes place each summer: manufacturers look at predictions from the World Health Organization for what the dominant flu strain will be the following winter and produce vaccines accordingly. The vaccine doses are typically booked well in advance by customers – around January – and there is very little oversupply. Solution When our client was ready to run the study, several manufacturers in the United States were already overbooked versus their production and would not have been able to support the requirements of the trial in all regions. CSI was able to leverage its longstanding relationship with a major European manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer, CSI demonstrated the equivalence of the EU and USA products. The trial also ran in some South East Asian countries; in order to bypass tricky import requirements, CSI sourced the product locally in these countries. Result With a flu vaccine trial, getting the sourcing wrong can be very costly. Failure to secure supplies would postpone the trial by a full calendar year since the Southern Hemisphere is a poor option when it comes to running a flu vaccine trial, having fewer countries and a circulation of poorly defined flu strains. CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the entire study. Without this strategy, the trial would have been delayed by one year at great expense to the sponsor. Case Study 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 Challenge To support a quadrivalent flu vaccine study by sourcing doses of a single product that was in short supply and managing delivery to multiple countries around the world Solution CSI’s relationship with an EU manufacturer secured the product in the quantity required for the whole trial, and equivalence between the EU and USA products was successfully demonstrated Result The time-sensitive study was safeguarded through a combination of CSI’s sound scientific and regulatory advice, and delivery of a robust sourcing solution Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit