We’re incredibly proud to announce that CSI has once again achieved the Platinum  EcoVadis  rating, for the second year in a row!  This places us in the top 1% globally for sustainability, ethics and corporate responsibility. It’s an incredible accomplishment and a testament to the values we live by every day. A huge thank you to our dedicated team for making this possible, your commitment continues to set us apart.

Earlier this month, the US President signed a landmark executive order aimed at delivering “most favored nation” (MFN) pricing for prescription drugs in the United States. As outlined in the official White House release  and covered by Reuters , the order seeks to tie US drug prices to those paid in other developed nations, potentially slashing prices by up to 59%. While much of the media focus has been on the implications for American patients, this shift also raises important questions for the pharmaceutical industry globally, especially in the area of clinical trials and comparator sourcing . What Could This Mean for Clinical Trials? The United States has long been the world’s most expensive market for prescription drugs. Sponsors planning global clinical trials often face disproportionately high costs when sourcing comparator drugs in the US If this executive order leads to significant price reductions, it could: Lower comparator drug costs in the US , making U.S.-sourced products more attractive in global studies. Influence global sourcing strategies , especially for trials requiring U.S.-sourced reference products due to regulatory or study design requirements. Encourage sponsors to re-evaluate US as a supply hub  for global studies, given improved cost efficiency. Implications for Comparator Sourcing At CSI, we specialize in comparator sourcing  across all therapeutic areas, with direct access to manufacturers in the US, Europe, and beyond. If the U.S. market becomes more cost-competitive, we could see: Increased demand for US-sourced comparators in global trials. Sponsors prioritizing US comparators to align with FDA expectations while managing budgets more efficiently. Potential shifts in global sourcing patterns, depending on how manufacturers respond to pricing pressures. With a strong presence in the US market and an office based in Philadelphia , CSI is uniquely positioned to support clients navigating this changing landscape. Our team’s expertise in US regulatory requirements, commercial networks and domestic distribution channels ensures that we can efficiently source, manage, and deliver US-sourced comparators. This local infrastructure allows us to act quickly and cost-effectively as policy shifts unfold, helping sponsors mitigate risk and take full advantage of emerging opportunities in the American market. A Wait-and-See Moment At this stage, the operational details of the executive order, including how it will be enforced, remain unclear. Manufacturer responses will also play a critical role. However, this is a pivotal development that could reshape drug pricing not only for patients but also for the clinical trial supply chain . As industry experts in comparator sourcing and supply strategy, CSI will be closely monitoring these changes and advising our partners on how best to navigate the evolving landscape. If you're planning a trial and want to discuss how this may impact your sourcing strategy, get in touch with our team .  We’re here to help you stay ahead of regulatory and market developments that affect your study timelines and budgets.

In clinical trials, every element of the supply chain matters. From sourcing high-quality comparator drugs to managing timelines across borders, sponsors often ask: which is the bigger challenge, drug sourcing or the logistics that follow? At Clinical Services International (CSI), we believe the answer isn’t either/or. It’s how you manage both that determines trial success. Comparator Sourcing: A Global Jigsaw Puzzle Sourcing comparator drugs can be a significant challenge, particularly when: The product is in short supply or under allocation. The trial requires access to brands from specific markets. There are tight timelines and narrow expiry windows. Sponsors need specific batches or documentation, such as Certificates of Analysis (CoAs) or TSE/BSE statements. The drug is subject to import/export restrictions. These complexities are amplified in regions with fragmented regulatory environments or limited distribution networks. That's why CSI maintains direct accounts with most major manufacturers and a global sourcing network , enabling us to secure even hard-to-source drugs quickly and compliantly. Clinical Trial Logistics: The Invisible Risk Even with comparators in hand, the real test often lies in getting those products to the right place, at the right time, and under the right conditions. Logistics hurdles can quietly derail a trial if not proactively managed. Some of the most critical challenges include: Cross-border customs delays. Temperature excursions during transit or at storage sites. Site-specific import requirements and licensing. Mismatched labelling and language translations. For global, multi-site, and especially Phase III trials , these risks are magnified. It’s essential to have a comprehensive strategy in place for management. The Role of Supply Chain Management CSI’s solution? Integrated supply chain management. We address both the sourcing and logistics to ensure smooth operations. How CSI Overcomes These Challenges At CSI, we don’t just source drugs; we de-risk the entire supply chain. Here's how: Strategic Forecasting & Planning CSI tailors supply strategies to align with projections, protocol timelines, and product shelf-life. This ensures optimal availability while minimizing waste. Accurate forecasting can prevent both shortages and excess inventory. Global Warehouse Network With facilities in over 60 countries , we provide flexible local storage options and rapid deployment capabilities. This logistical advantage enables us to respond quickly to changing circumstances. End-to-End Distribution From import/export documentation to temperature-controlled logistics, CSI manages every shipment from door to door with real-time oversight. Our comprehensive approach allows for transparency and awareness. Regulatory Expertise Our regulatory team provides site-specific support to ensure local compliance and smooth customs clearance. This is especially crucial in high-risk markets where regulations may change frequently. Returns & Destruction Post-trial, we handle compliant product returns, reconciliation, and destruction. This service takes the burden off sponsors and Contract Research Organizations (CROs), allowing them to focus on what they do best. Conclusion: It’s Not Either/Or. It’s Both While comparator drug sourcing is complex, particularly during global shortages or tight timelines, the logistical execution can be equally, if not more, fraught with risk. That’s why CSI takes an integrated approach. By combining sourcing expertise with robust supply chain capabilities, we help our clients move faster, stay compliant, and control costs, from protocol design through to last patient out. Need help solving a supply challenge? Contact CSI today to find out how we can support your trial from sourcing to final shipment.

Request A global listed Biotech company required large quantities of Eylea Pre-Filled Syringes (PFS)  sourced across both the EU and USA . Their priorities included: Relatively Stable pricing  over a 2-3 year period Best possible expiry dates  to accommodate packaging timelines (losing 6-8 weeks in the process) Ensuring continuous supply  by replenishing stock before expiry (~14-16 months) Bulk procurement  in single large batches for efficiency in regular intervals   Challenges Maintaining Cost Stability  – The client needed price consistency despite market fluctuations over multiple years. Expiry Date Optimization  – Ensuring the longest possible shelf life to offset packaging delays. Uninterrupted Supply Chain  – Stock replenishment had to be seamless, avoiding disruptions and putting patients at risk Large-Scale Procurement – Sourcing high volumes in one batch while maintaining quality and compliance. CSI’s Solution Strategic Bulk Sourcing:  CSI successfully procured thousands of units in USA and Europe in very large batches, securing availability and reducing procurement cycles. Pricing Stability Over 3 Years:  Thanks to strong, long-term relationships with strategic partners, CSI maintained consistent pricing despite market shifts. Direct Procurement from Manufacturer:  By sourcing, CSI ensured a short, secure, and reliable supply chain  with minimal risk.   Results & Impact Reliable, uninterrupted supply  for the client's clinical trial needs Optimized expiry dates  to maximize product usability post-packaging Cost-effective procurement , reducing financial uncertainty   At CSI, we deliver strategic, secure and cost-effective clinical supply solutions—ensuring trial success through efficient sourcing and supply chain expertise.

CSI attended the Global Clinical Supplies Group (GCSG) US Conference in San Antonio, Texas, April 27th-30th. The event brought 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, hosted a successful and sell-out workshop at GCSG US, to share over 25 years’ worth of expert insights on the complexities of comparator sourcing strategies. If you missed us, we’d love to connect. Reach out to schedule a meeting with our team!

We’re proud to share that CSI is now fully registered and qualified with  SAM.gov  and BARDA , enabling us to support U.S. government-funded clinical research programs—including those focused on vaccines and other high-priority areas. What does this mean for your team? ✔️ Eligibility for federally funded contracts and grants  ✔️ Faster onboarding for BARDA-backed projects  ✔️ Compliance with U.S. government clinical trial requirements  ✔️ Global readiness with our NATO NCAGE Code If your studies are backed by SAM, BARDA, or other federal agencies, we’re ready to provide seamless comparator sourcing and clinical trial supply solutions, fast. Let’s collaborate on your next government-funded trial. Reach out to learn how CSI can support your mission.

So are we! We’re pleased to share that Jonathan Miller , CSI’s Head of Operations, North America , will be attending Jefferies New York 2025  this June. If you’re a pharmaceutical or biotech company with comparator drugs in your pipeline, from early planning to on-demand global delivery, Jonathan would be happy to connect. Clinical Services International specializes in supporting complex, high-value clinical trials across all therapeutic areas. 📅 Let’s set up a meeting to explore how CSI can support your upcoming programs.

CSI attended and exhibited at Outsourcing in Clinical Trials 2022 in Barcelona on 4–5 May. It was an insightful conference as always, and we learned a lot from fellow speakers and attendees The main themes of this year’s OCT 2022 conference were: 1. Decentralised clinical trials and the regulatory framework to conduct such trials in Europe Clearly the pandemic has accelerated the need for flexible and innovative clinical trial solutions. Now, the provision of care and administration of medicines at the patients’ home is accepted as the new norm. At CSI, we have long been advocates of direct-to-patient supply. Direct-to-patient supply is an effective way to minimise disruption to the patients’ lives and improve their clinical trial experience. 2. Use of technology in clinical trials Technology provides many options that can facilitate the conduct of clinical trials, including: Data collection systems Digitisation and decentralisation Supply chain management IRT systems CSI uses advance technologies to give us complete visibility of the medicines we supply to clinical trials. Technology enables us to provide flexible supply solutions based on patient recruitment and demand, as well as firm control to minimise waste at site level. 3. Oncology updates Oncology studies represent a significant portion of clinical trials conducted worldwide. They do, however, present several challenges including patient recruitment. It is therefore critical to improve the efficiency of conducting clinical trials to overcome these challenges. At OCT Europe 2022, Joshua Ondatje from Worldwide Clinical Trials  gave an excellent presentation exploring adaptive designs that are more efficient, informative, and ethical. CSI has outstanding experience and expertise in supplying oncology medicines for trials all over the world, from Brazil and Mexico to Europe and China.

Ryvu Therapeutics Announces Entering into Agreement with Clinical Services International (CSI) in the Area of Securing Venetoclax Supply Chain for RVU120 Phase II Clinical Trial in Combination Therapy in Hematology Krakow, Poland and London, UK – Ryvu Therapeutics, a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, has entered into an agreement with Clinical Services International (CSI), a leader in sourcing, managing, and distributing certified commercially available medicines, comparators, concomitant medications, and rescue medications for clinical trials, in the area of securing venetoclax supply chain for the RIVER-81 study. The agreement is an essential element for the implementation of Ryvu's Development Plans for 2022-2024. The scope of the agreement is to provide supply chain-related services, including supply chain strategy, project management, procurement, storage, delivery, labelling, QP release, status monitoring and returns venetoclax in the RIVER-81 clinical study. The aim of the RIVER-81 study, a Phase II, multicenter, open-label clinical trial, is to evaluate the safety and efficacy of RVU120 in combination therapy with venetoclax for the treatment of patients with relapsed/refractory Acute Myeloid Leukemia (AML), who have failed prior therapy with venetoclax and a hypomethylating agent. The initiation of this study is planned for the second half of 2023. Kamil Sitarz, PhD, Management Board Member and Chief Operating Officer of Ryvu Therapeutics, said: “ The RIVER-81 study will have a global reach, spanning multiple clinical sites across the world. Given the complex nature of the combination therapy, it presents additional and substantial logistical and operational challenges. To effectively address these challenges, cooperation with service providers such as CSI is a standard and widely recognized practice in the market. By securing a reliable and efficient venetoclax supply chain, we can focus on schedule-compliant execution of the Phase II clinical trial of RVU120 in combination with venetoclax. Preclinical models have demonstrated strong synergy of RVU120 with venetoclax, providing solid reasons to believe that this combination therapy can significantly benefit patients suffering from AML.” Vanessa Dekou , PhD, MBA, Founder and Managing Director of Clinical Services International (CSI), said: "We are excited to partner with Ryvu on their RIVER-81 study. CSI and Ryvu will build an enduring and strategic relationship through this collaboration, and through our fully integrated service reduce costs and shorten timelines on their groundbreaking study. We are proud to have been chosen through Ryvu’s competitive selection process for our proven ability to procure medicines and manage the logistics of international studies. CSI’s partnership with Ryvu Therapeutics confirms our long-standing commitment to clinical research and best-in-class ability to support sponsors with complex global clinical trials." Venetoclax is a BCL-2 inhibitor that is approved in combination with a hypomethylating agent for the treatment of newly diagnosed AML in patients that are unfit to receive intensive induction chemotherapy. Its use has been widely adopted in the treatment paradigm. In the non-clinical studies, RVU120 was synergistic with venetoclax in both venetoclax-sensitive and venetoclax-resistant models. RVU120 is a selective, first-in-class dual CDK8/CDK19 kinase inhibitor that has shown signs of clinical activity in treated patients, as well as efficacy in numerous in vitro and in vivo models of hematologic malignancies and solid tumors. Currently, two dose escalation clinical studies of RVU120 are ongoing in patients with AML/HR-MDS and solid tumors. Results from the ongoing RVU120 study in AML/HR-MDS have shown a favorable safety profile and clinical benefit in 11 out of 24 evaluable patients (dose up to 135 mg, data cut-off on May 25).

Vanessa Dekou and the CSI Team attended the  Chelsea and Westminster Hospital NHS Foundation Trust  Gala last night in support of the  CW Plus Team  Thirty at Thirty appeal at Mansion House. Patient care is at the centre of what we do at CSI and 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.  To find out more and donate, follow the link: https://www.cwplus.org.uk/adc/V

CSI's Managing Director  Vanessa Dekou PhD, MBA  and Project Manager  Aylin Asadian  will be attending on the 9th October to discuss clinical trial supply with our industry associates. Book a meeting with the CSI representatives.

CSI is attending GCSG Europe, in Malta on the 15-17th October, the leading industry meeting where people get together to share knowledge and best practices.  CSI is at the forefront of advancements in clinical trial supply and are looking forward to sharing the recipe for success amongst all our friends and clients.  Visit our team of experts at booth PT-3 or pre-book meeting with our Managing Director, Vanessa Dekou PhD, MBA  and Associate Director  Stephan Mütze  to discuss your trial and protocol requirements.