As we prepare for Q1 2026, sponsors and CROs face a shifting global landscape for clinical trial comparator sourcing that focuses on sustainability, diversity and fair pricing. With our EcoVadis Platinum certification, women-owned business status and full scientific team in place, CSI is well placed to support our partner’s supply chains. 1. Supply-chain volatility is real Clinical supplies are increasingly challenged by geo-political pressures, export controls, and manufacturing concentration. Add to that evolving regulatory expectations (global CoA requirements, tighter comparator traceability), and sponsors need a partner with well-established manufacturer relationships. CSI’s direct accounts with major manufacturers puts us in a strong position to support complex comparator supply and to help you meet critical timelines. 2. Regulatory and pricing policy shifts are reshaping the industry In the US, Donald Trump’s administration has renewed focus on the “most-favoured nation” (MFN) pricing model: tying US drug prices to those paid in other comparable countries . For example, a landmark deal between Pfizer and the US Government commits to aligning US prices with developed‐world benchmarks and expanding domestic manufacturing. What does this mean for trial sponsors? Branded comparator supply may become subject to pricing/launch shifts; companies may delay or reprioritize markets to protect pricing globally. Demand for transparency, documentation and supply reliability will increase for all parties to manage risk. Suppliers who can offer robust supply assurance, global-ready documentation and diversified sourcing will gain an advantage. 3. Why this matters for your 2026 pipeline With pipeline activity increasing (NMEs, ATMPs, biosimilars) and sponsors under timer pressure, the comparator sourcing window is tightening. A partner who can deliver import/export guidance, traceability and contingency planning is critical. At CSI we combine: End-to-end comparator supply support Global documentation (including via our certified scientific team) Sustainability, ethical sourcing and a women-owned organisational profile that meets many corporate supplier diversity mandates Direct manufacturer access to cut out unnecessary middle-men and reduce lead-times 4. Actionable next steps for sponsors Audit your comparator sourcing providers now : Do your current partners adhere to lead times and regulatory documentation requirements? Ask your comparator supplier : Can they guarantee CoAs for every shipment, global registration‐ready documentation and alternative supply routes if challenges such as shortages arise? Consider regulatory/policy headwinds : The evolving US pricing environment means some branded drugs may face launch delays or pricing adjustments. Factor this into your comparator selection discussions. Partner with a supplier who understands both science and logistics : From molecule sourcing to clinical packaging, CSI can overcome these complexities. At CSI, we are ready to support your study needs, whether global or US, novel comparator or established branded. With our SAM.gov and BARDA approvals, women-owned status, EcoVadis Platinum certification and full scientific team, you get a partner who understands the end-to-end challenges and can act as your supply-chain ally. Ready to map your comparator strategy for 2026? Try us out for a quote.

Oncology products monopolise the list of best-selling drugs. With a huge range of indications that is only growing, therapies become more specific to tumour or cell pathologies and increasing patient numbers. Several oncology products now have ‘blockbuster’ status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. A significant proportion of the late-stage clinical trial pipeline is in oncology indications as immunotherapies and next-generation biotherapeutics are gearing up for approval. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often. Keytruda (Pembrolizumab) and Opdivo (Nivolumab) Number 2 and number 11 respectively in annual sales of oncology products are Merck’s Keytruda ($7.2B) and BMS’s Opdivo ($1.8B) . They are both checkpoint inhibitors targeted towards Programmed cell Death protein 1 (PD-1 inhibitors) that is responsible for downregulating the immune system that prevents the immune system from killing cancer cells. As both products target the same pathway, they naturally compete in many indications (Table 1). Keytruda Opdivo ​Melanoma Melanoma (in combination with Yervoy) Non-small cell lung cancer (as monotherapy and combination) Non-small cell lung cancer Urothelial carcinoma Urothelial carcinoma Classical Hodgkin lymphoma Classical Hodgkin lymphoma Head and neck squamous cell carcinoma Squamous cell cancer of the head and neck ​ Advanced renal cell carcinoma (in combination with Yervoy) Table 1: Indications for Keytruda and Opdivo. This means for many therapies, it is the physician’s choice whether to use Opdivo (often in combination with Yervoy) or Keytruda. Keytruda has been more successful in part due to its higher efficacy among all groups and reduced toxicity. Both of these products are incredibly popular in clinical trials; a search on clinicaltrials.gov shows that there are 783 studies recruiting using Keytruda and 707 for Opdivo. Herceptin (Trastuzumab) and Mabthera (Rituximab) Roche’s Herceptin and Mabthera come in at number 3 and 5, selling $7B and $6.8B respectively. They are highly effective therapies for HER-2 positive breast cancer (Herceptin) and Non-Hodgkin’s Lymphoma (Mabthera), two of the most common and widely treated cancers. However, the financial success of these products is under threat. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g. Celltrion’s Herceptin biosimilar – Truxima). As more trials show equivalency in outcomes between the branded and biosimilar product, more purchasers will choose the cheaper option. On clinicaltrials.gov , there are 246 recruiting studies with Trastuzumab and 415 with Rituximab; a growing proportion of them will choose the biosimilar. No product is safe from the encroachment of biosimilars, #4 (Roche’s Avastin – $6.8B) is also under threat as Amgen’s Mvasi has been approved by the Food and Drug Administration (FDA). As these blockbuster products continue to increase their market share and more trials are running globally utilising these products, sourcing them has become a hugely important part of a successful clinical trial. All the products mentioned come at a significant cost, running into the thousands per dose. It makes sense then to partner with an expert in sourcing to ensure the most efficient, risk-free, and cost-effective solution possible. Clinical Services International is a trusted partner of leading Pharmaceutical and Biotechnology Companies, Clinical Research Organisations, and Contract Manufacturing Organisations. We are experts in sourcing licensed and unlicensed medicines for use in trials, ranging from eye drops to the most sought-after blockbuster therapies.

Clinical trials are the backbone of medical advancement, providing the essential data to bring new therapies from the laboratory to the clinic. However, the complexities and costs associated with clinical trial supplies have been rising, making it challenging for many organizations to navigate the process effectively. Outsourcing has emerged as a strategy for managing these sourcing challenges and driving success in clinical trials. Here’s how to leverage outsourcing to ensure your clinical trials are successful. 1. Understanding the Need for Outsourcing Clinical trials involve multiple stages, each with unique requirements that demand specialised knowledge of markets and resources. These stages include protocol analysis, product sourcing, manufacturing and distributing. By outsourcing, Pharma and Biotech's can access expertise that may not be available in-house, reduce operational costs, and focus on core competencies.   2. Choosing the Right Partners The success of outsourcing in clinical trials hinges on selecting the right partners. Clinical Research Organizations (CROs) and specialized solutions providers are among the typical partners. Here are key factors to consider when choosing outsourcing partners: Experience and Expertise : Look for partners with a proven track record in your therapeutic area. CSI has successfully supplied more than 1000 trials worldwide and we have the most comprehensive knowledge in oncology supplies. In addition, direct accounts with more than 95 pharmaceutical companies and a network of warehouses in 60 countries enables us to deliver the most demanding adaptive trial. Regulatory Knowledge : Ensure they have a deep understanding of the regulatory landscape in the regions where your trials will be conducted. CSI has outstanding regulatory expertise in-house and has conducted trials across 45 countries in Europe, North and South America and Asia. Cultural Fit and Communication : Effective collaboration requires partners who align with your organisational culture and communication style. CSI has recently been awarded the Platinum EcoVadis Award, highlighting our commitment to a sustainable and ethical future in clinical trials. 3. Defining Clear Objectives and Expectations Clear objectives and expectations are crucial for any outsourcing relationship, by defining the scope of work, timelines, deliverables and quality standards from the outset. CSI develops comprehensive contracts to formalize these expectations and ensure accountability. 4. Maintaining Oversight and Quality Control While outsourcing can offload significant work, maintaining oversight is essential. CSI establishes regular communication via bi-weekly meetings to monitor progress and address any potential issues promptly and manages performance against well-defined KPIs, mutually agreed 5. Leveraging Technology Technology can enhance the efficiency and effectiveness of outsourced clinical trials. CSI invests heavily in research and has several extensive in-house database systems that enable us to monitor all regulatory requirements all over the world and can proactively offer solutions to our clients.     6. Fostering Long-term Relationships Building long-term relationships with outsourcing partners can provide ongoing benefits, such as enhanced trust, better collaboration and improved efficiency in future projects. Investing in these relationships can lead to more seamless integration and a deeper understanding of each party’s requirements and priorities.     Conclusion When executed strategically, outsourcing is a powerful tool to drive success in the clinical trial supply chain. It allows organizations to tap into specialized expertise and reduce operational burdens. By choosing the right partners, Pharma and Biotech companies can offload some of the the complexities of clinical trial supply effectively and focus on bringing new life-saving therapies to market.

By Clinical Services International As a proud Women-Owned Business , Clinical Services International (CSI)  is committed to transforming the global clinical supply landscape while championing gender equity and social responsibility. Founded on the principles of scientific excellence, ethical sourcing and diversity, CSI  stands at the forefront of pharmaceutical procurement and supply solutions for clinical trials worldwide. Women-owned businesses are vital to the global economy, bringing fresh perspectives, inclusive leadership and resilience. At CSI , our team, comprised of highly qualified women in science, brings industry expertise and a personal commitment to the highest quality standards. CSI’s Managing Director, Vanessa Dekou, has always been passionate about building a company culture grounded in inclusivity, integrity, and empowerment. As a woman in science and business, she recognized early on the importance of creating a workplace where individuals feel safe, respected, and supported regardless of gender, background or role. Our status as a Women-Owned Organization  not only differentiates us in the marketplace, but also strengthens our partnerships with pharmaceutical and biotech companies that prioritize supplier diversity and ESG (Environmental, Social, Governance) values. Beyond business, CSI  is dedicated to giving back. We actively support women’s charities, including the Ladies Union of Drama in Northern Greece , a grassroots organization that provides shelter, food, and vocational support to women and children in need. Through funding, donations and awareness campaigns, CSI helps empower vulnerable women and promote gender equality on a global scale. Our clients trust CSI not just for our reliable sourcing of comparators and clinical trial supplies, but also for our integrity, inclusivity and commitment to meaningful impact. As we continue to grow, we remain focused on advancing healthcare access while elevating the role of women in life sciences and beyond. For companies seeking a trusted, values-driven partner in clinical supply, CSI is uniquely positioned to deliver. Learn more about CSI’s mission and impact at www.csint.com

As part of our ongoing commitment to excellence and continuous improvement, CSI is proud to announce the digitalization of our Quality Management System (QMS) through Simploud , a leading eQMS platform.   This transition marks an important milestone in enhancing both our customer and supplier experience, ensuring greater efficiency, transparency and compliance across our global operations.   Simploud ’s unified platform will streamline key quality processes (including CAPA management, audits and document control) supporting CSI’s mission to deliver the highest standards in clinical supply solutions.   This reinforces CSI’s dedication to quality and innovation as we continue to advance our operations.   For full details, read our announcement.

October is Breast Cancer Awareness Month and  Clinical Services International (CSI)  is wearing pink to show our solidarity with the cause. Pink is the colour of the ribbon that represents breast cancer awareness. Wearing pink on this day is a way to express support for breast cancer survivors, remember those lost to the disease and advocate for the progress in the fight against breast cancer. Reach out to CSI for your Breast Cancer studies, let's beat Breast Cancer together.

Client Overview A global biopharmaceutical company approached CSI to support a Phase III oncology study requiring Opdivo (nivolumab) as a comparator. The study spanned 4 countries across North America, Europe and Asia-Pacific, with a target enrolment of over 500 patients. The client’s main objective was to ensure timely delivery of branded Opdivo for multiple trial sites while maintaining transparent, full chain of custody and documentation.   Challenge There were several key sourcing challenges: Global availability constraints  due to market-specific pack sizes and supply constraints in certain countries. Tight study timelines , with site activations beginning within 10 weeks of award. Import requirements  across multiple regulatory regions (EU, US and Japan). The open market procurement channels were unable to guarantee consistent supply across all territories.   CSI Solution CSI leveraged its direct manufacturer relationships and global sourcing network to deliver a customized solution: Direct Sourcing:  Opdivo was procured through   manufacturer-approved channels ensuring standardised product quality across batches. Regulatory Support:  CSI’s regulatory team managed Certificates of Analysis (CoA) and batch release documentation, ensuring compliance with each country’s import regulations. Global Distribution:  Shipments were distributed through CSI’s depots in the USA, Germany and Singapore, optimizing lead times and minimizing logistics costs. Risk Mitigation:  A dual-sourcing strategy was implemented to safeguard against regional shortages. Timeline Achievement:  First deliveries reached depots within 7 weeks of study award, three weeks ahead of schedule.   Outcome Delivered on-time to all global depots. No temperature excursions during transit (Opdivo is a cold-chain product). Full traceability and documentation across all shipments. The client extended CSI’s sourcing services to additional oncology programs, involving Keytruda and Tecentriq.   Key Highlights  Metric Result Study Scope 4 countries, 500+ patients Product Opdivo (Nivolumab) Delivery Time 7 weeks from award Compliance Full CoA and batch traceability Outcome 100% on-time delivery, no deviations     Conclusion CSI’s ability to provide fast-tracked and agile global sourcing allowed the sponsor to accelerate study initiation and avoid unnecessary costs. Through trusted manufacturer relationships, scientific expertise and global, cold-chain logistics capabilities, CSI delivered a seamless comparator sourcing solution that reinforced the client’s confidence in partnering for future studies.

At CSI, we’ve built our reputation on being a trusted partner in advancing global health. Among our proudest achievements is our role in supplying vaccines for clinical research across the world. With direct accounts with major vaccine manufacturers and a fully scientific team behind every project, CSI has supported countless studies, from large global programs to niche, targeted trials.   Our expertise ensures that vaccine supplies reach sites on time, fully compliant and with complete chain-of-custody transparency. What sets CSI apart? Proven Track Record: Years of experience across vaccine studies, including pandemic-response programs and long-term immunization trials. Global Reach: Navigating complex regulatory requirements in multiple regions with confidence. Scientific Rigor: Our project managers all have scientific backgrounds, guaranteeing a wealth of expertise behind every decision. Speed & Reliability: We minimize lead times, reduce approval delays and keep studies moving. At CSI, we understand that vaccines are lifelines. And in today’s world, where time and trust matter more than ever, our mission is clear: Nobody supplies vaccines better than CSI. Don't take our word for it, read our case study:

When it comes to sourcing medicines for Acute Myeloid Leukemia (AML), a supply partner with experience is imperative. At CSI, we’ve built a reputation as a world leader in delivering reliable and timely supply solutions that help drive AML studies forward. Our expertise spans across numerous global AML programs , partnering with leading pharmaceutical and biotech companies to ensure that clinical trials are never delayed due to supply chain challenges. With direct manufacturer accounts and a fully scientific team, CSI is uniquely positioned to secure the most critical therapies, even when availability is limited. What sets us apart? Proven Track Record : Years of supporting AML studies worldwide, from early-stage trials to late-phase programs. Global Reach : Access to key markets and the ability to navigate complex regulatory landscapes with precision. Scientific Excellence : Our entire project management team has scientific training, ensuring technical rigor in every study. Speed & Reliability : We shorten supply lead times and reduce approval delays, accelerating time to trial. At CSI, we know that every AML study carries extraordinary urgency and impact. That’s why we bring the highest level of commitment, knowledge, and execution to every project. Nobody does AML better than CSI. Don't take our word or it, read our AML supply case study:

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

At CSI, we understand the urgency and precision required in ophthalmology research. Among the most pressing areas is wet age-related macular degeneration (AMD)  a leading cause of vision loss worldwide. Clinical studies in this field demand not only specialized medicines, but also a reliable partner who can ensure seamless supply and global reach. With direct access to all major manufacturers, a fully scientific project team, and a proven track record across ophthalmology programs, CSI has supported numerous AMD studies  from early phase through to pivotal trials. What makes us stand out? Expertise : Years of experience navigating regulations in ophthalmology trials. Reliability : On-time supply with full compliance and chain-of-custody integrity. Global Reach : Delivering to sites worldwide, reducing study delays and accelerating patient access. Scientific expertise : Every project is managed by a team with strong scientific backgrounds, ensuring experience-based precision. At CSI, we know that every dose matters when it comes to vision-saving treatments. Our commitment to excellence makes us the trusted choice for ophthalmology clinical supplies. CSI leads the way in ophthalmology AMD supplies. Don't take our word or it, read our Ophthalmology Case studies:

In the pharmaceutical industry, timelines serve as both operational benchmarks and market signals. When sponsors announce trial starts and milestones, the investment community pays close attention. But what happens when behind-the-scenes issues, such as delays in sourcing a comparator drug, throw those timelines off track? At Clinical Services International (CSI), we have seen firsthand how comparator drug sourcing, though often underestimated, can become a critical path dependency for trial execution. This, in turn, affects investor confidence and market cap stability. Comparator Delays = Market Messaging Problems Investors understand scientific and clinical risk. However, they are far less forgiving of avoidable operational delays. For public companies, a delay in site activation, trial initiation, or patient enrolment due to unavailable comparator supply can lead to: Skepticism about operational competence A lowering of share price due to perceived risk Difficulty raising funds in future financing rounds Even in private biotech, delays in clinical timelines can cause hesitation from institutional investors. This can delay fundraising or weaken negotiating power. These delays often stem from incomplete sourcing strategies, last-minute purchasing, or dependence on unreliable supply chains. Why Comparator Sourcing is the Bottleneck Comparator drugs can be difficult to procure due to several factors: Market shortages or product allocations Limited manufacturer access or restrictive licensing Complex regulatory and documentation requirements Cross-border import/export complications, such as export bans If mitigation strategies are not addressed early, comparator availability can become a barrier before first patient in (FPI). This puts timelines and market promises at risk. How CSI Helps Sponsors Stay Investor-Ready At CSI, we align our supply strategy with your investor narrative. Here’s how we help safeguard your timeline: Early Sourcing Strategy We advise at the protocol design stage. This ensures that comparator sourcing and shelf-life are built into the project plan, rather than being addressed last-minute. Global Manufacturer Access Our direct accounts with branded and generic manufacturers ensure priority access to in-demand drugs. This helps to mitigate delays. Regulatory-Ready Documentation We eliminate delays at customs by providing full CoAs, TSE/BSE, and other necessary certificates. This streamlines the process. Global Fulfilment Network With warehousing and logistics partners in over 60 countries, we ship faster and more flexibly than traditional supplier pathways. This enhances our responsiveness to your needs. The Importance of Timely Supply Chain Management For clinical companies, time is more than just money; it’s market value. Comparator drug sourcing, often treated as a small part of clinical trials, can quietly become the biggest operational risk. When the market is watching, the difference between a delay and a delivery can mean everything. Conclusion: Your Market Cap Depends on Your Clinical Supply Chain In summary, securing your timeline is crucial before approaching investors or public markets. Delays in comparator drug sourcing can have far-reaching consequences. By addressing these issues proactively, you can enhance investor confidence and protect your market cap. Need to secure your timeline before you go to investors or public markets?