CSI’s Strategic Approach to Mitigating Clinical Trial Supply Disruption Recent developments in U.S. trade policy are shaking up supply chains, not just within the United States but worldwide. With the re-introduction of Trump-era tariffs on key goods, companies engaged in clinical research must rethink their sourcing and logistics strategies. Clinical Services International (CSI) is proactively addressing these challenges to support our clients amid this uncertain climate. Who's Affected and How? Several sectors within clinical research are particularly vulnerable to the reimposition of tariffs. It's essential to understand how each of these sectors can be impacted. Contract Research Organizations (CROs) Global CROs heavily rely on offshore labs and international logistics. They must now reassess their global sourcing strategies. Tariffs can inflate costs and disrupt timelines—an issue magnified across multicenter, multinational trials. Small and Mid-Sized Biotechs Resource-constrained sponsors face critical challenges due to even minor delays or cost increases. These sponsors often operate on tight budgets and timelines, making them particularly sensitive to supply chain disruptions and pricing instability caused by tariffs. Pharma Sponsors with Global Trials Large pharmaceutical companies conducting cross-border studies, such as those run by Pfizer, AstraZeneca, and BMS, encounter increased complexity. From sourcing comparators to ensuring regulatory compliance across regions, tariffs introduce new levels of risk into their global operations. Central Labs & Imaging Providers Companies that provide centralized laboratory services are struggling to import tariff-affected equipment, reagents, and technology. This has ripple effects on sample analysis timelines and trial coordination. Clinical Supply Distributors Distributors of kits, ancillaries, and packaging materials—particularly those relying on global networks—are being pushed to find domestic alternatives quickly. The Need for Change As tariffs continue to disrupt established supply chains, trial sponsors and CROs must pivot and adapt. It’s no longer just about cost; it’s about maintaining integrity and efficiency in clinical trials. CSI’s Strategic Response At CSI, we’ve built a resilient, globally distributed model designed to insulate our clients from the worst of these market shifts. Here’s how we’re positioned to help: Diversified Sourcing Network We maintain direct accounts with most major branded and generic manufacturers, allowing us flexibility in sourcing from regions less impacted by tariff implications. This ensures that our clients have consistent access to necessary supplies. Regional Warehousing & Cold Chain Solutions Our global footprint includes warehousing and cold chain capabilities across the EU, UK, US, and APAC. In the U.S., our state-of-the-art facility in Horsham, PA, is equipped to handle growing domestic demand. This helps clients bypass cross-border delays that can disrupt trials. APAC and LATAM Access Did you know CSI offers extensive access to APAC and Latin America? This provides alternative supply pathways for comparator drugs and trial materials, ensuring that we're prepared to adapt quickly to market changes. Regulatory Expertise We ensure end-to-end compliance with GDP, GMP, and ICH-GCP guidelines. Our team is skilled in navigating customs documentation and tariff classification processes, helping to avoid unnecessary delays or fees. Support for Biotechs and CROs From flexible minimum order quantities to agile sourcing for niche comparators, our scientific team is built to support the dynamic needs of small-to-mid biotech companies and CRO partners. We understand the cost and timeline pressures you face. Emphasizing Collaboration Collaboration is critical in overcoming the challenges posed by tariffs. At CSI, we believe in a partnership approach. We work closely with our clients to tailor strategies that meet their unique supply chain needs. Looking Ahead While the full economic and political implications of these tariffs unfold, one thing is evident: trial sponsors and CROs must employ a proactive approach. This is not just about managing costs; it's about forging resilient pathways for clinical supply. CSI is here to help you de-risk your clinical supply chain, maintain regulatory confidence, and keep your trial on track—no matter where it’s running. If you're rethinking your supply strategy in light of the new tariff climate, reach out to our team today to explore how we can help. index c

Which Trends Will Shape Clinical Trial Supplies in 2025? The clinical trial supply industry is rapidly evolving. This change is driven by the complexity of global studies and patient-centric approaches. As we approach 2025, key trends are set to reshape clinical supply solutions. CSI predicts that these changes will further emphasize the need for expert partners who can streamline operations and enhance trial outcomes. 1. Decentralized Clinical Trials (DCTs) Direct-to-patient (DTP) deliveries will become the norm. CSI can support sponsors by offering robust logistics frameworks. They provide advanced tracking systems and expertise in managing temperature-sensitive shipments. This ensures compliance, efficiency, and patient convenience. 2. Artificial Intelligence (AI) AI will optimize demand forecasting and inventory management. This will help to reduce waste and lower costs. CSI’s AI-integrated tools streamline supply chains. This technology is predicted to become indispensable for reducing trial delays and costs. 3. Localized Supply Networks As clinical trials expand globally, there will be a need for localized supply hubs. These hubs will be essential in Asia, Africa, and South America. CSI’s established global presence helps navigate diverse regulations. This ensures seamless quality and compliance across regions. CSI serves as a reliable partner in building and maintaining these vital networks. 4. Sustainability Eco-friendly practices will become standard. This includes biodegradable packaging and energy-efficient transport. CSI is committed to sustainable solutions. As an EcoVadis Platinum certified company, they focus on reducing the environmental impact of clinical supply chains. Sustainability will remain a top priority for the industry as companies align with global environmental goals. 5. Personalized Medicine There is a significant growth in personalized treatments, such as cell and gene therapies. This will demand flexible, patient-specific supply solutions and stringent cold chain management. CSI specializes in handling complex logistics for personalized medicine. They ensure timely and secure delivery. This trend will drive demand for precisely tailored supply chain solutions. 6. Advanced Analytics Real-time and predictive analytics will enhance supply chain performance. They will help mitigate risks and keep trials on schedule by identifying bottlenecks. Based on CSI’s experience utilizing the advanced analytics tool TraceLink, these analytics will play a pivotal role in future clinical supply strategies. This will help in avoiding supply delays. 7. Collaboration and Outsourcing Strong partnerships and outsourcing to specialized providers will be crucial. This is especially important for navigating complex trials. Trials often involve biologics, cancer therapies, and rare diseases. CSI’s proven expertise in global studies and tailored clinical supply solutions makes it a trusted partner for Biotech, Pharmaceutical, and CRO companies. The Future Landscape As we look ahead, the clinical trial supply landscape will continue to evolve. Emerging technologies will play a pivotal role. This includes the adoption of blockchain for enhanced transparency. As trials become more patient-centric, logistics will also need to adapt. In addition, the demand for data security will increase. Protecting patient information will be paramount as clinical trials scale. Technologies that focus on security will be essential in maintaining trust. Conclusion The clinical trial supply industry in 2025 will be defined by adaptability, sustainability, and technological advancement. CSI predicts that sponsors will increasingly rely on expert partners to navigate these challenges. Based on CSI's experience and market knowledge, they are uniquely positioned to support pharmaceutical and biotech clients with innovative tools and tailored solutions. CSI’s global reach ensures seamless operations, while its commitment to sustainability and advanced analytics drives efficiency. By embracing these trends, CSI serves as a trusted partner in accelerating drug development, ensuring more efficient trials, and delivering better outcomes for patients worldwide.

We’re excited to announce that Stephan Muetze , Director of Project Management, and Yasmine Clemson , Project Management and Marketing Associate, will be representing CSI at Clinical Trial Supply (CTS) Barcelona on 25th and 26th February. We don’t just support clinical trials—we inspire change, drive progress, and celebrate the power of diversity. Schedule a meeting here: www.csint.com/contact-us

Clinical Services International is thrilled to be recognized as the Top Clinical Trial Services Provider 2024 by Life Sciences Review! This award reflects our team's commitment to delivering exceptional clinical trial supply services and upholding our reputation within the industry.  We are grateful to our clients, partners and peers for their trust and recognition and to the expert panel that selected us after a thorough evaluation.

Request:  CSI was tasked with sourcing a vast quantity of Venetoclax and Azacitidine for a large pharmaceutical company's global study on Acute Myeloid Leukaemia, covering 17 countries in 3 continents.   Challenge:  The client needed to enroll patients within an extremely short timeframe of 6-months. Additionally, due to the global nature of the study, they also required Certificates of Analysis (CoA), making the feasibility of the request extra challenging.   Solution:  Leveraging CSI's strong partnership with AbbVie and generic manufacturers, we were able to cut the study approval time in half and reduce the supply lead time four-fold,  from four months to 4 weeks , including the required documentation. As a result, the client successfully delivered supplies to sites ahead of schedule.

Ensuring Efficiency, Compliance and Success Full supply chain management in clinical trial supply encompasses the comprehensive oversight and coordination of all activities involved in the sourcing, packaging, distribution and management of clinical trial comparator drugs and ancillaries. The goal is to ensure that these materials are available at the right place, at the right time, in the right condition, and in the correct quantities, all while complying with regulatory requirements and maintaining cost-effectiveness. Key components include:   1. Planning and Forecasting Demand Planning: Estimating the quantities of drugs and materials needed for the trial based on the study protocol (patient enrollment projections and trial design). Supply Planning: Scheduling procurement activities to meet the forecasted demand. 2. Procurement Sourcing Materials: Identifying and securing suppliers for active pharmaceutical ingredients (APIs), excipients and other necessary materials. Vendor Management: Establishing contracts, maintaining relationships, and ensuring supplier compliance with quality and regulatory standards. 3. Storage and Distribution Warehousing: Maintaining appropriate storage conditions (e.g., temperature, humidity) to preserve the integrity of trial materials. Logistics: Managing the transportation of materials to clinical sites, including handling customs and regulatory clearances for international shipments. 4. Inventory Management Tracking and Monitoring: Using CSI’s extensive data systems to monitor inventory levels, track shipments and manage stock. Resupply and Redistribution: Ensuring continuous availability of materials by resupplying sites as needed and redistributing excess stock to where it’s needed. 5. Regulatory Compliance Documentation and Record-Keeping: Maintaining accurate records of all supply chain activities for regulatory audits and inspections. Adherence to Guidelines: Ensuring compliance with regulatory standards, the FDA, EMA and MHRA and all other relevant authorities. 6. Risk and Waste Management Contingency Planning: Preparing for potential disruptions (e.g., supply shortages, logistical obstacles) and having mitigation strategies in place. Quality Assurance : Implementing quality control measures to ensure the integrity and safety of trial materials throughout the supply chain. Waste reduction: By analysing the study protocol in-house, we assess the patient numbers and incorporate drug expiry and product shelf-life into our supply strategy to minimize wastage. 7. Collaboration and Communication Client Communication: Engage in frequent meetings to address all queries and update our clients at each stage of the process. Information Sharing: Maintaining clear and consistent communication across all parties involved in the trial supply chain. In summary, full supply management in clinical trial supply ensures our clients can continue to focus on medical innovation and patient care. Selecting CSI as a supply partner allows your trials to run smoothly, efficiently and in compliance with all necessary regulations, contributing to the successful development of new therapies.

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.

How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Cetuximab is a type of monoclonal antibody, a targeted cancer drug used to treat advanced bowel cancer, and head and neck cancer, usually in combination with other anticancer treatments. In the United States, it was the first monoclonal antibody to be approved by the Food and Drug Administration (FDA) to treat patients with advanced metastatic colorectal cancer – i.e. cancer that has spread to other parts of the body. Challenge A listed global Biotech approached CSI with the challenge of sourcing cetuximab with Certificate of Analysis (CoA) in Belgium, France, Italy, Spain and Czech Republic for a European oncology trial. The product in question was scarce on the market at the time and the client had recently been let down by a competitor, so supply timelines were extremely tight – the first shipment was required in less than 8 weeks. To make matters more complex, a quota system had been introduced for the product in some markets, with suppliers receiving only a small quantity of the product as stock was needed to supply the local market. Solution CSI proved flexible in offering to start the work of sourcing and purchasing the product following receipt of email confirmation of the award of the study – before the client had even finalised the full scope of work and raised a purchase order – in order to condense timelines. We were then able to leverage our European supplier contacts to source the product very quickly and, within six days of the client’s original request, CSI had formed a comprehensive proposal for the client, including all costs for sourcing and distribution. Result The Blue-chip Biotech was able to proceed with their oncology study in Europe without delay to its timelines. CSI received glowing feedback from the client for its work in supporting this trial and has since been awarded further business from them.

Biopharmaceuticals have seen significant advances in recent years, particularly with the development of biologics and biosimilars. These innovative therapies have revolutionised the treatment landscape for various diseases, offering targeted and personalised approaches. Currently, 80% of the top-selling pharmaceuticals are biologics and, as the demand for these therapies continues to rise, the development of biosimilars has had a significant positive impact on costs for clinical trials, helping to bring safe and effective drugs to market at an affordable price. Understanding Biologics and Biosimilars Biologics are therapeutic agents derived from living organisms such as humans, animals or microorganisms. They are large, complex molecules that include proteins, antibodies and nucleic acids. Biologics are the new standard of care and have opened new avenues for the treatment of conditions such as cancer, auto-immune disorders and genetic diseases, offering enhanced efficacy and reduced side-effects in comparison to traditional small molecule drugs. Biologics are protected by patents, which grant exclusive rights to the originator company for a specific period. This exclusivity allows the originator company to charge premium prices for their products, which has a significant impact on the cost of clinical trials. However, when patents expire, biosimilar manufacturers can enter the market, leading to increased competition and potential price reductions for clinical trials. Biosimilars are highly similar versions of approved biologics (referred to as ‘reference medicines’ or ‘originator medicines’) and are designed to be comparable in terms of structure, quality, safety and efficacy. These follow-on versions offer an opportunity to provide more affordable alternatives to costly biologics, expanding patient access to life-changing therapies. CSI’s Sourcing Expertise CSI specialises in sourcing biologics and biosimilars and has supplied them to more than 700 oncology studies around the world: Biologic Number of Studies Phase of Trial Geography Pembrolizumab 50+ 1, 2, 3 Europe, USA Aflibercept 50+ 1, 2, 3 Europe, USA, Latin America Nivolumab ​ 50+ 1, 2, 3 Global Ipilimumab 50+ 1, 2, 3 Global Biologics and biosimilars that CSI has successfully supplied to studies globally: Adalimumab Cetuximab Daratumumab Adalimumab Adalimumab Trastuzumab Bevacizumab Infliximab Ustekinumab Rituximab Filgrastim Pegfilgrastim While increased complexity, regulatory requirements, manufacturing challenges and intellectual property considerations have all contributed to the rising cost of biologics, the emergence of biosimilars has introduced competition and attendant price reductions. As the field continues to evolve, it is crucial to strike a balance between the need for innovation and affordability to ensure the continued development and accessibility of these groundbreaking therapies. Read more about what to consider when purchasing biosimilar products and further information about CSI’s sourcing capabilities. Read more about biosimilars in clinical trials and key regulatory considerations.

It’s Sustainability Month at CSI and we will be focusing on all things ESG (Environmental, Social, and Governance). Clinical Services International (CSI) achieved the Platinum EcoVadis award, scoring in the Top 1% of companies rated for categories ‘Environment’, 'Labour & Human Rights', 'Sustainable Procurement' and 'Ethics', showing our commitment to a greener future in clinical trial supply. ESG stands for Environmental, Social, and Governance and is a framework used to evaluate and measure the sustainability and societal impact of a company. 🌳Environmental: This aspect focuses on how a company performs in terms of its impact on the environment. It includes factors such as carbon emissions, energy efficiency, waste management and resource conservation. CSI launched the robust Green Plan program in December 2022 to provide clear guidance that creating a greener environment is a key responsibility to minimize negative impacts on the environment on all 5 key aspects below: 🚮Waste reduction 🛒Sustainable Procurement ✈️Carbon emissions 💡Energy efficiency 🌿Resource conservation We work diligently with our partners at each stage of the clinical supply chain to share and implement best sustainable practices. 🧑‍🤝‍🧑 Social: This aspect assesses how a company manages its relationships with employees, clients, suppliers, and the communities in which it operates. Social factors include: ✅Labour practices ✅Diversity and inclusion ✅Human rights and ethics ✅Community support ✅Safety CSI ensures that every step of our clinical trial supply chain is environmentally conscious, socially responsible and governed with integrity. This begins with supporting six local and global charities and focusing on the training and wellbeing of our staff. Integrating social considerations alongside environmental and governance factors is essential for building trust, promoting sustainability and advancing responsible clinical trial supply chain practices. 💼 Governance: This aspect examines the quality of a company's corporate governance structure and practices. In the context of clinical trial supply chains, the 'Governance' aspect of ESG (Environmental, Social, and Governance) refers to the policies, procedures, and structures in place to ensure that ethical principles, regulatory requirements, and industry standards are upheld throughout the clinical trial supply process. Our policies include, but are not limited to: 💠 Supplier Diversity Programme 💠Environmental and Sustainability Policy 💠Corporate Social Responsibility (CSR) Policy 💠Modern slavery Policy 💠Equality and Diversity Policy 💠Anti-corruption Guidelines 💠Sustainable Procurement Policy 💠Human Rights Policy By prioritizing governance principles alongside environmental and social considerations, organizations can promote responsible and sustainable clinical research practices.

The CSI Team is excited to be attending the Outsourcing in Clinical Trials (OCT) Europe Conference in Barcelona on the 7th-8th May. Our Associate Director Stephan Mütze and Project Manager Aylin Asadian will be showcasing CSI's clinical supply chain expertise and experience at Booth 71.

CSI's Director of Strategy, Andrea Giochetta is attending BioNJ's BioPartnering Conference at the Liberty Science Centre in New Jersey on May 14th, 2024. This will be an opportunity to connect with US industry associates in Pharma and Biotech and showcase CSI's full clinical supply chain expertise.