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.

Browse our top comparator medicines with CoA, including leading oncology and biosimilar products, available through qualified global manufacturers and suppliers. Upcoming Events Stay up to date with where you can meet the CSI team next. Here you’ll find the conferences and industry events we’re attending, with dates, locations, and booth or session details. If you’re a sponsor, CRO, or CMO, book a meeting to discuss comparator sourcing, global clinical trial supply, and end-to-end logistics. Check back for updates or use the links below to schedule time with us. Schedule a meeting for our next event Test conference Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut Book a meeting 19 December 2025 Expopharm Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Book a meeting 11 November 2025 CTS Conference Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Book a meeting

How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets More case studies Ensuring batch-consistent, compliant comparator supply across NA, EU, and APAC - on time and uninterrupted. Read all Effective Sourcing of Semaglutide for a Global Phase III Clinical Trial From supply shortfall to on-time first-patient-first-visit across Europe, delivered in three days. Read all CSI's 72-hour Abraxane Rescue Mission Adaptive, multi-product supply across 22 countries and 80 sites, kept on time, in budget and compliant. Read all CSI’s Expert Delivery of a Global Respiratory Study A leading global biopharmaceutical company urgently requested CSI to supply the Fluarix QIV Southern Hemisphere Vaccine for 2025. Read all Rapid Sourcing of Discontinued Southern Hemisphere Vaccine for a Global Biopharmaceutical Client Securing reliable, cost-effective, long-term supply of Eylea PFS from EU and USA for a global biotech company’s clinical studies. Read all Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies A biotech client asked CSI to source Lucentis for a Phase II ophthalmology trial. Read all Comparator Sourcing for a Phase II Ophthalmology Study CSI Efficiently Delivered Venetoclax and Azacitidine Across 17 Countries Read all How CSI streamlined Venetoclax and Azacitidine supply across 17 countries in record time Export of expensive comparators from Europe to China with first leg documents and streamlined approach Read all CSI’s seamless comparator export to China CSI’s flexible approach to global distribution ensured a large CRO's five-year and three-year studies across a total of 18 countries could proceed without delay Read all Global Device Distribution How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Read all Rescuing a Global Biotech's Oncology Study with Cetuximab How CSI fulfilled what our competitors couldn’t: rapidly sourcing oncology medication from the EU for a trial in South Korea Read all Rescuing a Biotech’s Oncology Trial with Lenvima How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price Read all Delivering €1 million Savings for Pembrolizumab Challenge A client approached CSI with a very specific request: to test samples of an expensive oncology product before purchasing the same batches that had passed the testing stage. This was a challenging assignment as it required visibility of batches currently on the market before purchasing, which is only possible in certain markets where product availability is moderate. Due to the nature of the trial, the client was not willing to disclose trial details and required documentation (Certificate of Analysis and Pedigree documents). Solution Without the possibility of disclosure, we had to source the product from the open market. This was challenging because we had to fulfil four requirements: Batch testing Advance visibility of batches Product from specific batch available Documentation The most effective solution was to work with our audited suppliers to devise a ‘hit list’ of batches that had had a positive result in testing. This required close cooperation with suppliers in those markets where batch visibility and documentation were possible, to keep an up-to-date list of batches on the market at any given time, and whether they had had a positive or negative test. Result At CSI, we pride ourselves on implementing effective sourcing strategies for even the most complex trials. In this case, our high level of market knowledge resulted in the successful delivery of the required product and ensured the client’s trial never ran dry. This type of sourcing strategy is dependent on very close communication between CSI, the client, and our suppliers. As suitable markets usually have limited availability, the product had to be collected over time before being delivered to the client in bulk. Guaranteeing a stable supply chain to the client, and ultimately the patient, was paramount at all times. CSI also leveraged its strong relationships with suppliers to keep stock on hold, with the promise to purchase if the batch testing was successful. This solution is only possible when mutual trust exists between all parties, there is a deep understanding of the specific trial requirements, and you have a united team with the determination to deliver for the benefit of the patient. Case Study Oncology Product Batch Hunting How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Challenge To supply an oncology product for a client’s trial, with a caveat: a sample from each batch had to be tested before purchasing the bulk Solution We worked closely with suppliers to hunt specific batches in several European markets where batch visibility and documentation were possible Result CSI’s scientific expertise and knowledge of trial regulatory requirements delivered a strategy that enabled the client’s trial to begin without delay Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit

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