CSI’s Strategic Approach to Mitigating Clinical Trial Supply Disruption Recent developments in U.S. trade policy are shaking up supply chains, not only in the US but globally. With the revival of Trump-era tariffs on key goods and international suppliers, companies involved in clinical research must rethink their sourcing and logistics strategies. At Clinical Services International (CSI), we are proactively addressing these challenges to support our clients through this uncertain climate.   Who's Affected and how? According to recent analysis, several sectors within clinical research are particularly vulnerable to the reimposition of tariffs: Contract Research Organizations (CROs) Global CROs rely heavily on offshore labs and international logistics and must now re-evaluate their global sourcing strategies. Tariffs can inflate costs and disrupt timelines — an issue magnified across multicenter, multinational trials. Small and Mid-Sized Biotechs For resource-constrained sponsors, even minor delays or cost increases can be critical. These sponsors are often operating on tight budgets and timelines, making them disproportionately sensitive to supply chain disruptions and pricing instability caused by tariffs. Pharma Sponsors with Global Trials Large pharmaceutical companies conducting cross-border studies — including those run by Pfizer, AstraZeneca, and BMS — face increased complexity. From sourcing comparators to ensuring regulatory compliance across regions, tariffs inject new levels of risk into their global operations. Central Labs & Imaging Providers Companies that provide centralized laboratory services are facing challenges importing 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 — especially those relying on global networks — are being pushed to find domestic alternatives quickly.   CSI’s Strategic Response At CSI, we’ve built a resilient, globally distributed model that insulates our clients from the worst of these market shifts. Here’s how we’re positioned to help: Diversified Sourcing Network We have direct accounts with most major branded and generic manufacturers, enabling us to offer flexibility in sourcing from regions less affected by tariff implications. Regional Warehousing & Cold Chain Solutions Our global footprint includes warehousing and cold chain capabilities across the EU, UK, US, and APAC. In the US, our state-of-the-art facility in Horsham, PA is equipped to handle growing domestic demand, helping clients bypass cross-border delays.  APAC and LATAM Access Did you know CSI offers extensive access to APAC and Latin America, providing alternative supply pathways for comparator drugs and trial materials. Regulatory Expertise We ensure end-to-end compliance with GDP, GMP, and ICH-GCP guidelines — including navigating customs documentation and tariff-classification processes 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 facing cost and timeline pressure. Looking Ahead While the full economic and political scope of these tariffs is still unfolding, one thing is clear: trial sponsors and CROs must take a proactive approach. CSI is here to help you de-risk your clinical supply chain, maintain regulatory confidence, and keep your trial on track — wherever 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.

A Leading Biotech Client's Challenge A leading biotech client approached CSI to assist in sourcing the comparator drug Lucentis for a Phase II ophthalmology clinical trial. This project demanded precise planning and timely execution. It was crucial to ensure an uninterrupted supply across multiple global sites. The client prioritized batch consistency and Certificates of Analysis (CoA) for all supplies. Understanding the Challenges The biotech company faced several hurdles in sourcing Lucentis. Being a high-demand ophthalmology drug, there was limited availability in the required markets. This scarcity made it challenging to find adequate supplies. Moreover, the client needed detailed Certificates of Analysis (CoA) for each batch. This was essential to guarantee the quality of the drug and meet regulatory requirements across different countries. To make matters more complex, the client required a single batch to maintain uniformity throughout the study and avoid variability in trial results. The study also had stringent timelines, which left no room for delays in procurement or delivery. Developing the Perfect Solution Leveraging Expertise and Network CSI leveraged its expertise and global network to address the client’s needs effectively. By utilizing established relationships with manufacturers and distributors, the team managed to secure sufficient quantities of Lucentis. This strategy considered multiple purchases throughout the study, taking into account the shelf life of the product. Additionally, the sourcing strategy concentrated on regions with regulatory alignment to the study’s requirements. Through careful planning, CSI sourced Lucentis from the same production lots whenever possible. This approach ensured batch-to-batch consistency, a critical element for clinical trials. Implementing Robust Logistics CSI also implemented a robust logistics plan to minimize lead times. This logistical strategy was vital to ensure on-time delivery to all global trial sites. The planning process involved thorough coordination with suppliers and logistics partners. By doing so, CSI aimed to finalize its supply chain efficiently. Successful Outcome Meeting Regulatory Standards As a result of these combined efforts, the client’s Phase II ophthalmology study proceeded without any delays or supply interruptions. By securing Lucentis with complete CoA documentation and maintaining compliance, CSI ensured the trial’s integrity. This, in turn, helped accelerate the approval process. The client acknowledged that CSI’s contribution was instrumental in meeting their ambitious timelines and achieving study milestones. This successful collaboration not only improved the supply chain's efficiency but also reinforced CSI's position as a trusted partner in the biotech field. Key Takeaways Precision in Planning : The importance of thorough planning and precise execution cannot be overstated, especially in clinical trials. Sourcing Challenges : Understanding the complexities of drug sourcing is essential for successful clinical trial management. Logistics Matter : A robust logistics strategy is crucial for ensuring timely delivery and avoiding interruptions in supply. Regulatory Compliance : Maintaining regulatory standards through proper documentation is vital for the integrity and success of clinical trials. By focusing on these key areas, CSI effectively navigated the challenges posed by sourcing Lucentis and ensured the successful execution of the Phase II clinical trial. This collaboration highlighted the importance of strong partnerships and strategic planning in achieving clinical research goals. To learn more about achieving successful clinical trials and sourcing solutions, check out CSI's services .

We are excited to announce that CSI will be attending the Global Clinical Supplies Group (GCSG) US Conference in San Antonio, Texas, April 27th-30th. This event brings together clinical supply professionals from around the world to discuss industry trends, challenges and strategies for your clinical trial pipeline. CSI’s Managing Director, Vanessa Dekou, will be hosting a workshop at GCSG US, to share over 25 years’ worth of expert insights on comparator sourcing strategies. The Complexities of Comparator Sourcing Workshop Times: April 28th : 10:15-11:15 April 29th: 11:15-12:15 If you’re attending GCSG US, we’d love to connect. Reach out to schedule a meeting with our team!

Clinical Services International (CSI) USA Operations delivers expert clinical trial solutions across North America, ensuring efficient supply chain management and streamlined access to medicines. Supporting Clinical Trials Across the Americas—and Beyond At Clinical Services International (CSI), our USA operations play a vital role in providing global clinical trials with local expertise, regulatory knowledge and logistical capabilities. Our USA base—centered in Horsham, Philadelphia, PA—allows us to support clients in America with exceptional access to manufacturers, a high-performing distribution hub and a deeply experienced project management team. USA Operations US Warehouse Global Reach, Local Expertise Did you know CSI supports clinical studies in over 45 countries across North America, Europe, Latin America, Asia-Pacific and the Middle East. With our USA presence, we seamlessly integrate sourcing, packaging, labelling and logistics to meet the demands of complex, multinational clinical trials. Our team understands the regulatory frameworks of the FDA, EMA, MHRA and other global health authorities, ensuring a compliant and efficient supply chain across borders. Our Services - Our Global Reach Warehouses and offices Our network extends to 60 countries on six continents What We Do in the USA? Whether you're running a Phase I trial in the USA or managing a global Phase III study, we ensure consistent, secure, and timely delivery of critical clinical supplies. At our state-of-the-art warehouse in Horsham, PA, CSI provides end-to-end services, including: From direct accounts with USA manufacturers and authorized distributors Comparator Sourcing Comparator sourcing Temperature-controlled storage solutions Storage and Distribution Cold-chain logistics In accordance with global regulatory standards Packaging Clinical packaging & labelling With full traceability Warehouses Inventory and expiry management By USA-based experts with global coordination Project Management Project management Across North and Latin America Shipments Direct-to-site and depot shipments Did You Know? CSI has excellent access to markets in APAC and Latin America , thanks to our established global supplier network and regional logistics partnerships. That means we can ship comparator and ancillary supplies directly to your sites—wherever they are—without delay. Why Pharmaceutical and Biotechnology companies choose CSI for their USA Studies Fast turnaround times across the Americas Reliable access to branded and generic medications Fully qualified suppliers and temperature-controlled logistics Regulatory support for import/export and labelling compliance Experienced scientific and project teams with deep therapeutic knowledge Let's connect Need comparator drugs, ancillaries or clinical trial supply support in the USA or globally? Reach out to our team today and discover how CSI can make a difference in your study's success Book a meeting with Jonathan -> Philadelphia Head of Operations, North America Jonathan Miller An experienced director and entrepreneur, Jonathan leverages his global business development and operational abilities to identify areas for CSI to expand its strategic footprint. By combining business automation and integration, Jonathan focuses on fostering relationships and building upon CSI’s core competencies. Before joining CSI, Jonathan served as the Director of Business Development and Product Marketing in a fintech organization and as the founder of a boutique marketing agency focused on the high-tech industry. He holds a B.S. in Applied Economics & Management with a concentration in finance from Cornell University. Find our CSI US warehouse easily - click the links below to open directions in your preferred navigation app and ensure smooth access to our facility. US Warehouse – Directions & Location -> graph Medical equipment Technological equipment Print materials START Electrocardiogram (ECG) tests Spirometers Weighing scales Blood pressure monitors Infusion pumps Cooled or uncooled centrifuges Refrigerators Visit our Sustainability page eDiaries Mobile devices Laptops Printers Pill splitters Investigator site files Pharmacy binders Patient recruitment material Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit Company type

Discover how CSI is making a difference through charity and philanthropy, committed to positively impacting communities and supporting meaningful causes globally. CSI’s Commitment to Giving Back At CSI, we believe in giving back to our communities. Our charitable initiatives span a wide range of causes, reflecting our commitment to making a positive impact both locally and globally. As part of our dedication to community support, CSI provides all employees with one paid day each year to participate in charity work of their choice. In addition, we proudly contribute to the following organizations and initiatives: Charity & Philanthropy Cambridge MBA Scholarship (UK) Supporting the next generation of leaders in Science CSI is proud to have 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. CSI is a great believer that education creates opportunities, so the scholarship aims to assist scientists advance their business understanding and credentials in order to become part of the next generation of leaders and contribute to scientific advancement. In addition, Vanessa, Founder and Managing Director of CSI, is a member of the Advisory Board of Cambridge Judge Business School. 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. Vanessa Dekou - 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. Gishan Dissanaike - Dean of Cambridge Judge Business School Enhancing healthcare for local communities Enhancing healthcare for local communities We donate generously each year through funding and support to CW+, the official charity of Chelsea and Westminster Hospital NHS Foundation Trust, which encompasses Chelsea and Westminster Hospital, West Middlesex University Hospital and all our community-based services and serves a population of more than 1.5 million people. Our contribution aims to enhance ongoing delivery of outstanding care to the communities the Trust serves through a plethora of innovative initiatives, pilots of new clinical services and trials of cutting-edge technology, which lead to improved clinical practice and greater understanding of effective treatments. Vanessa, Founder and Managing Director of CSI, is a member of the Innovation Advisory Group of CW+. Queen Mary University of London Digital Environment Research Institute (DERI), PhD Scholarship. CSI is proud to be an industry partner supporting a PhD position at Queen Mary University of London in collaboration with Singer Instruments. This research focuses on uncovering mechanisms of mTOR inhibition resistance through drug repurposing, interactomics, and AI—a vital step in advancing drug discovery and improving treatment outcomes. As part of the UKRI/BBSRC AI for Drug Discovery Programme, this project will contribute to cutting-edge innovation in the pharmaceutical space Ladies Union of Drama (Greece) Empowering women through education and resources. We aspire for our contribution to be community-led and sustainable, to build community capacity and support social welfare, public health and social care. As such, we donate generously each year through funding to community groups and organizations that support diverse and inclusive communities. Our focus during the past year has been the Ladies Union of Drama, Greece, an award-winning small-scale non-profit philanthropic agency with big impact. The purpose of the Ladies Union of Drama is to offer social and humanitarian work in the community of citizens and, especially, of vulnerable social groups. They aim to educate and develop solidarity, combat of gender violence, xenophobia and racism, raise public awareness on issues of equality, equity, human and democratic rights, support of fellow citizens. graph Battersea Foil Promoting sports in youths. Battersea is a small club with good overseas and London connections. The club has a 50:50 male to female ratio, and has a number of fencers on sponsored places, with the club running on a not-for-profit basis. We are proud to financially support and inspire young athletes to start, stay and succeed in fencing. Battersea Foil Website Arcangelo Supporting excellence in music and the arts Arcangelo is an award-winning, internationally-acclaimed period performance ensemble led by its founder and artistic director Jonathan Cohen. A registered charity, receiving no state funding, Arcangelo replies upon the generosity of individuals and companies such as ours, who believe that young musicians should be nurtured and supported to develop their skills and talent. Arcangelo Website Chcepomagam Foundation (Poland) Helping those in need through various social projects. We contributed with several packages of medicines such as nose drops, cough medicine and analgesics to the Chcepomagam Foundation to aid their provision for humanitarian aid in Ukraine. Humanitarian aid has reached several important places in Ukraine including Special Centre for Mother and Child in Drohobych, Mixed Children's Home "Oranta" in Drohobych, Regional Specialist Children's Home in Nadvirnay, Ivano-Frankivsk Special School – Rehabilitation Center in Ivano-Frankivsk. Chcepomagam Foundation Website Queen Mary University of London Digital Environment Research Institute (DERI), PhD Scholarship. CSI is proud to be an industry partner supporting a PhD position at Queen Mary University of London in collaboration with Singer Instruments. This research focuses on uncovering mechanisms of mTOR inhibition resistance through drug repurposing, interactomics, and AI—a vital step in advancing drug discovery and improving treatment outcomes. As part of the UKRI/BBSRC AI for Drug Discovery Programme, this project will contribute to cutting-edge innovation in the pharmaceutical space Project Page In Action Our team actively participates in charitable events. CSI’s UK Marketing Associate Yasmine represented CSI in the 2024 ‘La Montpellier Reine’ race against Breast Cancer. The CSI Team attended the Chelsea and Westminster Hospital NHS Foundation Trust Gala in support of the CW Plus Team Thirty at Thirty appeal at Mansion House. It was an honour to be a part of this charity fundraising event, in aid of our local hospital. New Cancer and Renal Disease centres are underway. At CSI, we strive to create meaningful change, one initiative at a time. Medical equipment Technological equipment Print materials START Electrocardiogram (ECG) tests Spirometers Weighing scales Blood pressure monitors Infusion pumps Cooled or uncooled centrifuges Refrigerators Visit our Sustainability page eDiaries Mobile devices Laptops Printers Pill splitters Investigator site files Pharmacy binders Patient recruitment material

We provide world-leading, bespoke clinical trial supply chain solutions focusing on comparator sourcing At CSI, we take a scientific approach to comparator sourcing based on our 150 years of experience in the clinical trial supply industry. Comparators are on the critical path of almost all clinical studies but are increasingly expensive and hard to find. We pride ourselves on finding the unfindable, sourcing comparator drugs that allow clinical trials to run on time and provide better patient outcomes. Comparator Drug Sourcing The clinical supply partner of choice Pharmaceutical companies , biotechnology companies and Clinical Research Organisations (CROs) must have robust comparator sourcing strategies in place to ensure that comparator drugs are supplied to all clinical trial sites at a competitive price and without disruption. CSI has supplied medicines to over 1,200 clinical trials across lifecycle phases 1 to 4, supporting our partners with even the most complex and challenging requirements. We understand that every clinical study is different and requires a customised approach. With the experience to take on even the most complex adaptive trials, we know how to reduce complexity and drive value, delivering sourcing strategies to improve the speed and agility of your study. CSI delivers results with: A comprehensive understanding of clinical trial requirements and protocols Fully bespoke sourcing solutions, whether country-specific, global or hybrid A global network of qualified suppliers, manufacturers and wholesalers A wide range of suppliers to minimise risks and enable sourcing of specific batches Full documentation, client support and supply chain transparency CSI’s six drivers of effective comparator sourcing Understanding the science behind a clinical trial informs CSI’s efficient supply strategies Protocol interpretation Protocol interpretation Product access Product access Supply continuity Supply continuity Cost control Cost control Speed Speed Supporting documents Supporting documents Our most frequently supplied comparator medicines Humira adalimumab Arthritis Eylea aflibercept Ophthalmology Tecentriq atezolizumab Oncology Bavencio avelumab Oncology Avastin bevacizumab Oncology Yervoy ipilimumab Oncology Abraxane nab-paclitaxel Oncology Opdivo nivolumab Oncology Ibrance palbociclib Oncology Keytruda pembrolizumab Oncology Lucentis ranibizumab Ophthalmology Stivarga regorafenib Oncology Mabthera rituximab Oncology Jakavi ruxolitinib Oncology Talzenna talazoparib Oncology Roactemra tocilizumab Arthritis Branded Name Scientific Name Indication Overcoming the challenges of comparator drug sourcing The sourcing of comparator drugs and non-investigational medicinal products (NMPs) has become increasingly critical as most drugs are now tested against the standard of existing care. Despite market growth and development, it is becoming more difficult to guarantee the timely availability of comparator drugs due to many of the products being biologic medicines , which are difficult to produce and distribute. Working with CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner. Our scientific expertise means we can advise on new investigative drugs and, with our global reach and emphasis on quality , you can always rely on us to deliver. Case Studies Oncology Products Biosimilars Oncology Products CSI specialises in supplying oncology products to global clinical trials. We have successfully delivered oncology products to more than 1000 studies, from generics to the most sophisticated cold chain biologics Discover more Biosimilars CSI has extensive experience of supplying biosimilar medicines to a wide range of clinical trials, including the navigation of strict government regulations around the world. Our strong relationships with leading manufacturers and our global network of trusted suppliers make us the ideal supply partner for biosimilars. Discover more Comedications The standard of care for many indications, especially in oncology, is now a combination of drugs that together provide maximum efficacy. Comedications may be used to alleviate side effects or to improve the potency of the treatment. Comedications are common in cancer treatment because of the multitude of biological mechanisms at play in disease progression. Combination therapies play a crucial role in the comprehensive care of patients, from managing risks to creating synergies that give the gold-standard of treatment. Critically, for clinical trials, the increasing prevalence of combination therapies being used as comparators means more complexity and greater risk from delays, drug shortages, disruptions and compromised supply chains. Securing multiple products on time, and in the right condition, is even harder when each requires a different supplier and logistics solution. CSI has the expertise and experience to help our partners to overcome these challenges. Our scientifically-minded team has the knowledge to advise on the optimal sourcing strategy for all comedications and combination therapies that might be required for any trial, factoring in origin of supply, price, logistics and shipment timing. Rescue Studies We apply our same expertise, global footprint and operational excellence in service of global studies that may need rescuing, whether this relates to issues of procurement, sourcing, resource, compliance, quality or timelines. With CSI’s decades of experience in the clinical trial supply industry and dedicated client relationship managers, we are here to help you get your study back on track. CSI has sourced rescue medications for a range of global studies, including the supply of salbutamol, Remicade (infliximab), Jakavi (ruxolitinib) and mycophenolate motefil. Case Study