Ensuring Efficiency, Compliance and Success Full supply chain management in clinical trial supply encompasses the comprehensive oversight and coordination of all activities involved in the sourcing, packaging, distribution and management of clinical trial comparator drugs and ancillaries. The goal is to ensure that these materials are available at the right place, at the right time, in the right condition, and in the correct quantities, all while complying with regulatory requirements and maintaining cost-effectiveness. Key components include:   1. Planning and Forecasting Demand Planning: Estimating the quantities of drugs and materials needed for the trial based on the study protocol (patient enrollment projections and trial design). Supply Planning: Scheduling procurement activities to meet the forecasted demand. 2. Procurement Sourcing Materials: Identifying and securing suppliers for active pharmaceutical ingredients (APIs), excipients and other necessary materials. Vendor Management: Establishing contracts, maintaining relationships, and ensuring supplier compliance with quality and regulatory standards. 3. Storage and Distribution Warehousing: Maintaining appropriate storage conditions (e.g., temperature, humidity) to preserve the integrity of trial materials. Logistics: Managing the transportation of materials to clinical sites, including handling customs and regulatory clearances for international shipments. 4. Inventory Management Tracking and Monitoring: Using CSI’s extensive data systems to monitor inventory levels, track shipments and manage stock. Resupply and Redistribution: Ensuring continuous availability of materials by resupplying sites as needed and redistributing excess stock to where it’s needed. 5. Regulatory Compliance Documentation and Record-Keeping: Maintaining accurate records of all supply chain activities for regulatory audits and inspections. Adherence to Guidelines: Ensuring compliance with regulatory standards, the FDA, EMA and MHRA and all other relevant authorities. 6. Risk and Waste Management Contingency Planning: Preparing for potential disruptions (e.g., supply shortages, logistical obstacles) and having mitigation strategies in place. Quality Assurance : Implementing quality control measures to ensure the integrity and safety of trial materials throughout the supply chain. Waste reduction: By analysing the study protocol in-house, we assess the patient numbers and incorporate drug expiry and product shelf-life into our supply strategy to minimize wastage. 7. Collaboration and Communication Client Communication: Engage in frequent meetings to address all queries and update our clients at each stage of the process. Information Sharing: Maintaining clear and consistent communication across all parties involved in the trial supply chain. In summary, full supply management in clinical trial supply ensures our clients can continue to focus on medical innovation and patient care. Selecting CSI as a supply partner allows your trials to run smoothly, efficiently and in compliance with all necessary regulations, contributing to the successful development of new therapies.

How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Cetuximab is a type of monoclonal antibody, a targeted cancer drug used to treat advanced bowel cancer, and head and neck cancer, usually in combination with other anticancer treatments. In the United States, it was the first monoclonal antibody to be approved by the Food and Drug Administration (FDA) to treat patients with advanced metastatic colorectal cancer – i.e. cancer that has spread to other parts of the body. Challenge A listed global Biotech approached CSI with the challenge of sourcing cetuximab with Certificate of Analysis (CoA) in Belgium, France, Italy, Spain and Czech Republic for a European oncology trial. The product in question was scarce on the market at the time and the client had recently been let down by a competitor, so supply timelines were extremely tight – the first shipment was required in less than 8 weeks. To make matters more complex, a quota system had been introduced for the product in some markets, with suppliers receiving only a small quantity of the product as stock was needed to supply the local market. Solution CSI proved flexible in offering to start the work of sourcing and purchasing the product following receipt of email confirmation of the award of the study – before the client had even finalised the full scope of work and raised a purchase order – in order to condense timelines. We were then able to leverage our European supplier contacts to source the product very quickly and, within six days of the client’s original request, CSI had formed a comprehensive proposal for the client, including all costs for sourcing and distribution. Result The Blue-chip Biotech was able to proceed with their oncology study in Europe without delay to its timelines. CSI received glowing feedback from the client for its work in supporting this trial and has since been awarded further business from them.

Biopharmaceuticals have seen significant advances in recent years, particularly with the development of biologics and biosimilars. These innovative therapies have revolutionised the treatment landscape for various diseases, offering targeted and personalised approaches. Currently, 80% of the top-selling pharmaceuticals are biologics and, as the demand for these therapies continues to rise, the development of biosimilars has had a significant positive impact on costs for clinical trials, helping to bring safe and effective drugs to market at an affordable price. Understanding Biologics and Biosimilars Biologics are therapeutic agents derived from living organisms such as humans, animals or microorganisms. They are large, complex molecules that include proteins, antibodies and nucleic acids. Biologics are the new standard of care and have opened new avenues for the treatment of conditions such as cancer, auto-immune disorders and genetic diseases, offering enhanced efficacy and reduced side-effects in comparison to traditional small molecule drugs. Biologics are protected by patents, which grant exclusive rights to the originator company for a specific period. This exclusivity allows the originator company to charge premium prices for their products, which has a significant impact on the cost of clinical trials. However, when patents expire, biosimilar manufacturers can enter the market, leading to increased competition and potential price reductions for clinical trials. Biosimilars are highly similar versions of approved biologics (referred to as ‘reference medicines’ or ‘originator medicines’) and are designed to be comparable in terms of structure, quality, safety and efficacy. These follow-on versions offer an opportunity to provide more affordable alternatives to costly biologics, expanding patient access to life-changing therapies. CSI’s Sourcing Expertise CSI specialises in sourcing biologics and biosimilars and has supplied them to more than 700 oncology studies around the world: Biologic Number of Studies Phase of Trial Geography Pembrolizumab 50+ 1, 2, 3 Europe, USA Aflibercept 50+ 1, 2, 3 Europe, USA, Latin America Nivolumab ​ 50+ 1, 2, 3 Global Ipilimumab 50+ 1, 2, 3 Global Biologics and biosimilars that CSI has successfully supplied to studies globally: Adalimumab Cetuximab Daratumumab Adalimumab Adalimumab Trastuzumab Bevacizumab Infliximab Ustekinumab Rituximab Filgrastim Pegfilgrastim While increased complexity, regulatory requirements, manufacturing challenges and intellectual property considerations have all contributed to the rising cost of biologics, the emergence of biosimilars has introduced competition and attendant price reductions. As the field continues to evolve, it is crucial to strike a balance between the need for innovation and affordability to ensure the continued development and accessibility of these groundbreaking therapies. Read more about what to consider when purchasing biosimilar products and further information about CSI’s sourcing capabilities. Read more about biosimilars in clinical trials and key regulatory considerations.

More case studies 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 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 How CSI supplied large quantities of ruxolitinib to a CRO’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read all Global CRO Oncology Partnership How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read all Oncology Product Batch Hunting How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries Read all Delivering Comparators for a Global Allergy Study How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule Read all Sourcing Flu Vaccines for a Global Trial How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline Read all Rapid Oncology Study Supply How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read all Streamlining Biotechnology Supply Chains How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read all Overcoming Drug Shortages Challenge A recent example of the flexibility and efficiency of CSI’s Quality team was their response to the unforeseen unavailability of a chosen warehouse for the storage of a country-specific product due to be supplied to one of our partners’ ongoing clinical trials. Due to unforeseen circumstances at the warehouse, the intermediate storage of the medication became impossible at very short notice. Since the re-supply date for the medication was in less than 10 days’ time, rapid action was required to maintain timely supply for the trial. Solution While it is critical to the success of any study to ensure that Quality standards are upheld and regulations followed, there is sometimes also need to be adaptable to respond to shifting priorities in ongoing studies. As such, CSI’s Project Management team reached out to our Quality team with viable alternatives to the original warehouse. The Quality team proceeded to adjust their working hours to facilitate immediate communication with the new warehouse located on the other side of the globe. Result Having successfully gathered all documentation required, and after performing a full audit and qualification of the warehouse in just 5 days, the efforts of CSI’s Quality team ensured consistent supply of the product required for our partner’s clinical trial that was in progress and could not afford to be delayed. This was an excellent display of efficiency and collaboration between CSI and the new warehouse’s Quality teams. Case Study A Quality Solution to Clinical Trial Supply How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial Challenge At short notice, intermediate storage of a medication sourced for a partner’s clinical trial was no longer possible at a specified warehouse Solution CSI’s Quality team adjusted their working hours to facilitate immediate communication with a new warehouse located on the other side of the world Result All required documentation was gathered to perform a full audit and qualification of the warehouse in just five days, resulting in timely trial supply Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit Company type

More case studies 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 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 How CSI supplied large quantities of ruxolitinib to a CRO’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read all Global CRO Oncology Partnership How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial Read all A Quality Solution to Clinical Trial Supply How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read all Oncology Product Batch Hunting How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries Read all Delivering Comparators for a Global Allergy Study How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule Read all Sourcing Flu Vaccines for a Global Trial How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline Read all Rapid Oncology Study Supply How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read all Streamlining Biotechnology Supply Chains How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read all Overcoming Drug Shortages Challenge A leading pharmaceutical company reached out to CSI to source expensive comparators for their study running in China. Navigating the meticulous regulatory landscape for exporting medicinal goods into China was a challenge, requiring provision of an extensive list of documentation, including a Certificate of Origin (COO) and the First Leg Document which encompasses a Certificate of Conformity (CofC), Certificate of Analysis (COA), commercial invoice, packing list, airway bill, drug product chain of custody, and shipping invoice. There was also added logistical complexity involved in coordinating multiple shipments of sensitive, temperature-controlled medicines across different countries and time zones. Result The success of the trial depended on CSI’s timely import and export of the comparators while maintaining compliance with Chinese regulations. CSI’s collaboration with a trusted global logistics partner resulted in a streamlined transport and tracking process, minimising delays and ensuring the integrity of the product during transit. This case study highlights the importance of regulatory expertise, logistical efficiency and meticulous documentation management and well-established relationships with pharmaceutical manufacturers for the success of global clinical trials. Solution Our dedicated team of project managers and Quality department leveraged their comprehensive understanding of import/export requirements and strong relationship with the manufacturer to directly obtain the CoO and compile all the necessary documentation for inclusion with the shipments. Once the product had cleared customs in China, CSI established close communication channels with our global logistics partner, who has a strong presence in the country and is experienced in handling pharmaceutical shipments, including temperature-sensitive clinical trial supplies. This ensured facilitate real-time updates on shipment status, which could in turn be relayed to the client. Case Study CSI’s seamless comparator export to China Export of expensive comparators from Europe to China with first leg documents and streamlined approach Challenge A leading pharmaceutical company reached out to CSI to source expensive comparators for their study running in China. Result CSI obtained all necessary approvals and licences, ensuring compliance with Chinese regulations and the smooth import of medicines into China. Solution CSI Successfully managed to obtain the First Leg Documents thanks to our longstanding relationship with manufacturer and this significantly reduced the risk of customs clearance issues, enabling timely entry of clinical trial supplies into China. Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit Company type

More case studies 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 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 How CSI supplied large quantities of ruxolitinib to a CRO’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read all Global CRO Oncology Partnership How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial Read all A Quality Solution to Clinical Trial Supply How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read all Oncology Product Batch Hunting How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries Read all Delivering Comparators for a Global Allergy Study How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule Read all Sourcing Flu Vaccines for a Global Trial How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline Read all Rapid Oncology Study Supply How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read all Streamlining Biotechnology Supply Chains How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read all Overcoming Drug Shortages Challenge A listed global Biotech approached CSI with the challenge of sourcing cetuximab with Certificate of Analysis (CoA) in Belgium, France, Italy, Spain and Czech Republic for a European oncology trial. The product in question was scarce on the market at the time and the client had recently been let down by a competitor, so supply timelines were extremely tight – the first shipment was required in less than 8 weeks. To make matters more complex, a quota system had been introduced for the product in some markets, with suppliers receiving only a small quantity of the product as stock was needed to supply the local market. Solution CSI proved flexible in offering to start the work of sourcing and purchasing the product following receipt of email confirmation of the award of the study – before the client had even finalised the full scope of work and raised a purchase order – in order to condense timelines. We were then able to leverage our European supplier contacts to source the product very quickly and, within six days of the client’s original request, CSI had formed a comprehensive proposal for the client, including all costs for sourcing and distribution. Result The Biotech was able to proceed with their oncology study in Europe without delay to its timelines. CSI received glowing feedback from the client for its work in supporting this trial and has since been awarded further business from them. Case Study Rescuing a Global Biotech's Oncology Study with Cetuximab How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Challenge To source cetuximab with CoA in several European countries to rescue an oncology trial for a Biotech who had been let down by a competitor Solution CSI proved its agility and flexibility, leveraging its supplier relationships and sourcing the product within six days of the client’s request Result The Biotech was able to proceed with their oncology study without delay and CSI has since been awarded further business from them Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit Company type