CSI is exhibiting at Outsourcing in Clinical Trials (OCT) New England! Our Executive Vice President  Jean Bowtell  and Designated Representative  Jessica Rodriguez  look forward to meeting US executives and trial sponsors for three incredible days of networking and innovation.  Book a meeting and visit CSI’s Booth 35 to discuss your supply requirements, your success is our mission.

CSI are attending and presenting at Clinical Trial Supply (CTS) East Coast!  Vanessa Dekou PhD, MBA  will be speaking at 12:30pm, Stream A on Day 1 to discuss the challenges in sourcing comparators on a global scale and remedies to mitigate risk even for the most complex phase III adaptive trials.  Book a meeting with CSI’s Managing Director  Vanessa Dekou PhD, MBA , Executive Vice President  Jean Bowtell  and Project Manager  Molly Dear .

CSI are presenting at the Clinical Outsourcing Group (COG) Conference in Amsterdam on 12th-13th November.  As the leader in clinical trial supply,  Vanessa Dekou PhD, MBA  will be sharing insights and best practices for success with our valued partners and clients. If you will be attending, join  Vanessa Dekou PhD, MBA  and  Jan de Witt  at Booth 28 to discuss your full supply chain requirements and reach out to us to book a meeting.

CSI was honored to be invited to   GSK ’s Supplier Diversity Fair yesterday! As a certified Women Owned business with a multicultural, 70% female workforce and a platinum EcoVadis rating, we’re proud to be recognized for our commitment to sustainability - values that align closely with GSK’s own vision. We thoroughly enjoyed the presentations highlighting the importance of corporate responsibility and diversifying procurement practices. Thank you, GSK , for fostering a space to drive these critical conversations forward!

At Clinical Services International (CSI), we continually strive to exceed the expectations of our pharmaceutical and biotech partners by delivering reliable clinical supply solutions. We are thrilled to announce a significant milestone in our journey: CSI has obtained a Controlled Drugs License. This achievement marks a pivotal step in our commitment to supporting clinical trials with comprehensive, compliant, and efficient sourcing services for any products required. Expanded Sourcing Capabilities The UK Controlled Drugs License grants CSI the authority to handle, store and distribute controlled substances in accordance with regulatory standards. Controlled drugs require meticulous handling and strict adherence to regulatory compliance. With this license, CSI is now equipped to: Source Controlled Drugs : Partner with trusted suppliers to procure high-quality controlled substances for clinical trials. Ensure Compliance and Safety : Uphold the highest standards of regulatory compliance to safeguard patient safety. Streamline Clinical Trials : Provide end-to-end support in sourcing controlled substances, reducing lead times and accelerating trial timelines. This capability enhances our value proposition as a one-stop solution for clinical trial supplies, particularly for complex studies requiring specialized materials. Meeting Trial Requirements in a Complex Landscape Controlled substance comparators are required for the development of groundbreaking therapies for pain management, central nervous system disorders and other critical conditions. Navigating the regulatory landscape for controlled drugs is challenging due to country-specific requirements, stringent licensing protocols, and rigorous security measures. At CSI, we understand these complexities and are prepared to handle them efficiently. Our team of experts is trained to manage the sourcing, storage and distribution of controlled substances, ensuring every step of the process complies with applicable laws and guidelines. This license reinforces our commitment to alleviating the logistical and regulatory burdens faced by our clients, enabling them to focus on advancing science and improving patient outcomes. This license aligns with CSI’s broader mission to be a leader in clinical supply solutions. By extending our capabilities, we are better positioned to serve our clients with the agility and expertise they require. About CSI Clinical Services International (CSI) is a trusted partner for pharmaceutical and biotech companies, specializing in global clinical trial supply solutions. From comparator drug sourcing and storage to distribution and regulatory compliance, CSI ensures the seamless execution of clinical trial supplies worldwide. We are ready to assist you with your clinical supply needs for controlled drugs. Reach out to our team to learn how CSI can support your next clinical trial.

CSI will be exhibiting at Booth 21 to meet  Vanessa Dekou PhD, MBA , our Managing Director, along with our Project Manager and Marketing Associate and Head of Business Development  Michael Vertheim .  Let’s discuss how CSI can support your comparator sourcing needs with our global expertise, direct manufacturer relationships, and industry-leading sustainability. We look forward to connecting with you!

Client Request A leading global biopharmaceutical company approached CSI with an urgent need for the Fluarix QIV Southern Hemisphere Vaccine 2025 . The requirements included: Quantity : 10,000 doses Delivery Date : As soon as possible (urgent) Delivery Location : Singapore Batch Preference : Multiple lots acceptable if necessary The Challenge The client was let down by a supplier in Brazil and needed to secure alternative stock at the last minute. Complicating matters, the Fluarix QIV Southern Hemisphere vaccine had been discontinued in many markets , significantly limiting global availability. Timing was critical, as vaccine allocations were closing and stock was being committed through pre-bookings. CSI’s Solution CSI acted immediately to onboard the client rapidly , understanding the urgency and complexity of the request. Within just one week of initial contact, CSI identified a secure supply of the correct Southern Hemisphere strain  of the vaccine, also working to obtain this in a single batch . The opportunity to secure the stock was limited, requiring pre-booking within days  to avoid the doses being allocated elsewhere. Thanks to CSI’s agility, experienced market access and expertise in comparator sourcing, the client was successfully onboarded in record time and the stock was secured and delivered on time. Outcome Following the initial successful delivery, the client requested additional doses . While the pre-booking period had closed and most stock had been allocated, CSI continued to monitor regional availability. By working closely with local marketing authorization holders , CSI was able to secure an additional 2,000 units  as bookings began to release — ensuring the client’s continued access to this hard-to-source vaccine. Client Impact The client was highly satisfied with the speed, professionalism and outcome of CSI’s service and has since engaged CSI for further sourcing support.

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 .

Exciting news! CSI will be exhibiting at GCSG Asia Pacific 2024 this week, on March 12-13 in Seoul! Visit us at Table 7 to learn how our expert clinical supply solutions can streamline your global trial supplies.  Let’s connect and explore how CSI’s direct manufacturer relationships, scientific expertise and sustainable sourcing can support your study needs. See you there! 👋

A Global Pharmaceutical Sponsor’s Challenge A global pharmaceutical sponsor conducting a Phase III clinical trial needed Semaglutide, a GLP-1 receptor agonist, as a comparator drug. The study spanned multiple regions, including North America, Europe, and Asia-Pacific. This required a consistent and compliant supply of the drug across various regulatory landscapes. The sponsor needed a reliable partner to source Semaglutide efficiently while ensuring batch consistency, Certificates of Analysis (CoA) availability, and regulatory compliance for each region. The Challenges of Sourcing Semaglutide Sourcing Semaglutide for a global clinical trial presented several notable challenges: Limited Market Availability: Semaglutide is a high-demand medication, with strict allocation policies from manufacturers. This made it difficult to secure enough supply. Regulatory Complexities: Different countries have unique regulatory requirements, including import/export restrictions and various regional documentation needs. Navigating these complexities can be daunting. Supply Constraints: Ensuring batch consistency across all study sites while managing complex logistics and potential delays was crucial. Stringent Quality Standards: The need for CoAs, shelf-life requirements, and temperature-controlled handling was essential for the drug’s stability and effectiveness. An Innovative Solution from Clinical Services International (CSI) To overcome these challenges, Clinical Services International (CSI) leveraged its expertise and established relationships with manufacturers. They successfully sourced and delivered Semaglutide for the trial through a multi-faceted approach: Direct Sourcing CSI’s established accounts with major pharmaceutical manufacturers enabled a streamlined procurement process. This ensured that Semaglutide was secured with batch consistency across all sites. Regulatory and Quality Assurance CSI took responsibility for regulatory compliance by carefully managing import/export documentation. They obtained region-specific approvals and provided CoAs for every batch of Semaglutide. This attention to detail ensured that the medication met all requirements in each region. Global Logistics Management CSI’s expertise in supply chain logistics played a critical role. They enabled temperature-controlled shipments with end-to-end tracking, ensuring that deliveries arrived on time at study locations worldwide. Risk Mitigation Strategy A proactive risk management plan was implemented. This included backup supply strategies and contingency logistics to minimize the risk of supply interruptions. Such foresight was essential in ensuring the uninterrupted supply of Semaglutide. Achieving Successful Outcomes Thanks to CSI's dedicated efforts, the organization successfully delivered Semaglutide to all global sites, ensuring the clinical trial progressed without interruptions. The pharmaceutical sponsor reaped numerous benefits from this strategic partnership: Reduced lead times and minimized regulatory delays. A consistent and high-quality supply of the comparator drug. Significantly diminished risks associated with sourcing challenges. Conclusion: Seamless Supply Chain Solutions By partnering with Clinical Services International, the sponsor ensured a seamless supply chain for Semaglutide. This arrangement enabled the Phase III clinical trial to progress on schedule while maintaining compliance across all regions. The successful sourcing of Semaglutide highlights the importance of collaboration and expertise in the complex landscape of global clinical trials. In summary, effective sourcing can greatly impact the success of a clinical trial. For sponsors looking to navigate similar challenges, working with a reliable partner is key. Ensure that you collaborate with experts who can handle rigorous regulatory requirements and guarantee a steady supply of essential medications, making your clinical trial journey smoother and more efficient. If you have any specific questions or need assistance with sourcing Semaglutide, feel free to reach out for more information.