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 More case studies --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- --------- Read all -H1---fORTitle-- -- ---H1--forTitle-- ----- ------ ---- --P1-----forRichtext------------ --- --- Title --- ---- --- --- ---fORTitle --- --- ---- --- ----- ------ ----- ------- -- -- ------ - -forSubtitle --- ----- -- ------ ----- ------- -- -- --------- ---H1 -fORTitle-- --- --- --- ---- --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- ---------

CSI Efficiently Delivered Venetoclax and Azacitidine Across 17 Countries More case studies --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- --------- Read all -H1---fORTitle-- -- ---H1--forTitle-- ----- ------ ---- --P1-----forRichtext------------ --- --- Title --- ---- --- --- ---fORTitle --- --- ---- --- ----- ------ ----- ------- -- -- ------ - -forSubtitle --- ----- -- ------ ----- ------- -- -- --------- ---H1 -fORTitle-- --- --- --- ---- --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- ---------

How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market More case studies --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- --------- Read all -H1---fORTitle-- -- ---H1--forTitle-- ----- ------ ---- --P1-----forRichtext------------ --- --- Title --- ---- --- --- ---fORTitle --- --- ---- --- ----- ------ ----- ------- -- -- ------ - -forSubtitle --- ----- -- ------ ----- ------- -- -- --------- ---H1 -fORTitle-- --- --- --- ---- --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- ---------

How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price More case studies --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- --------- Read all -H1---fORTitle-- -- ---H1--forTitle-- ----- ------ ---- --P1-----forRichtext------------ --- --- Title --- ---- --- --- ---fORTitle --- --- ---- --- ----- ------ ----- ------- -- -- ------ - -forSubtitle --- ----- -- ------ ----- ------- -- -- --------- ---H1 -fORTitle-- --- --- --- ---- --- p1----- forSubtitle ------ ----- ------- -- -- ------ - - --- ----- -- ------ ----- ------- -- -- ---------

All Posts Insights News Events Case Studies Latest News Featured Clinical Services International (CSI) Aug 6 Insights Comprehensive Clinical Trial Supply Chain Management Ensuring Efficiency, Compliance and Success Full supply chain management in clinical trial supply encompasses the comprehensive oversight... Clinical Services International (CSI) Jun 27 Case Studies Case Study: CSI's expert delivery of a global respiratory study CSI managing complex adaptive supply chain of a respiratory study in 22 countries Request CSI received a request from a Blue Chip,... Clinical Services International (CSI) Jun 21 Featured Successful Outsourcing of Clinical Trial Supplies Clinical trials are the backbone of medical advancement, providing the essential data to bring new therapies from the laboratory to the... Clinical Services International (CSI) May 24 Insights Sustainability and ESG is a priority at CSI It’s Sustainability Month at CSI and we will be focusing on all things ESG (Environmental, Social, and Governance). Clinical Services... Clinical Services International (CSI) May 23 News CSI attended the CW+ Fundraiser Vanessa Dekou and the CSI Team attended the Chelsea and Westminster Hospital NHS Foundation Trust Gala last night in support of the CW... Clinical Services International (CSI) May 2 Latest News CSI ARE IN THE TOP 1% OF BUSINESSES 🌟 CSI is extremely proud to announce our Platinum EcoVadis Award, signifying the highest level of recognition for corporate sustainability... Clinical Services International (CSI) Apr 29 Events CSI is attending the BioPartnering Conference CSI's Director of Strategy, Andrea Giochetta is attending BioNJ's BioPartnering Conference at the Liberty Science Centre in New Jersey on... Clinical Services International (CSI) Apr 29 Events CSI is attending Outsourcing in Clinical Trials (OCT) Barcelona The CSI Team is excited to be attending the Outsourcing in Clinical Trials (OCT) Europe Conference in Barcelona on the 7th-8th May. Our... Clinical Services International (CSI) Apr 3 Insights Understanding Ancillaries in Clinical Trial Supply Ancillaries play a crucial role in ensuring the smooth execution of clinical trials, encompassing a broad range of items, materials and... Clinical Services International (CSI) Mar 13 Events CSI is exhibiting at GCSG US 2024! CSI is attending GCSG US in Naples, Florida on 21st-24th April at the Hyatt Regency Coconut Point Resort and Spa. Visit Booth 4 to speak... Clinical Services International (CSI) Mar 1 Insights Clinical Supply Logistics: A Key Pain Point for Biotech and Pharmaceutical companies The management of clinical supply logistics has emerged as a particular challenge for Contract Research Organizations (CROs) serving... News and Insights

All (142) Blog Posts (85) Other Pages (57) 142 items found for "" Blog Posts (85) Comprehensive Clinical Trial Supply Chain Management 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. 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 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. The Evolution of Biologics and Biosimilars 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. View All Other Pages (57) Clinical Services International (CSI) | Quality Meeting the highest standards makes all the difference CSI serves communities and makes a difference to people’s lives by supplying safe and ethically sourced medications to clinical trials across the world. Maintaining compliance with global sourcing regulations and logistics is an essential part of meeting the highest standards of quality and safety. Quality Expert regulatory advice Sourcing and distributing medicines and medical devices globally requires extensive knowledge of regional regulations that differ from country to country. CSI’s regulatory and quality assurance experts have longstanding relationships with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and provide advice and solutions for your clinical trial supply requirements. Country-specific regulatory expertise Highest standards of quality and safety Relationships with regulatory agencies Independent quality department Independent quality department At CSI, we pride ourselves on our robust quality assurance processes that guarantee the quality of every product we supply to your clinical trial. Our independent and well-established quality department ensures regulatory compliance across all our processes and all territories in which we operate around the world. We are fully compliant with Falsified Medicines Directive (FMD) Good Distribution Practice (GDP) Good Manufacturing Practice (GMP) Good Storage Practice (GSP) We can provide Certificates of Analysis (CoAs) Batch Release Certificates (BRCs) Statements of Authenticity (SoAs) Proactive supply chain management Early sourcing of a comparator drug ensures that a reliable and compliant clinical supply chain can be established. By conducting thorough and proactive quality control checks throughout the entire supply chain, CSI identifies and mitigates any quality issues before they come to fruition. Our global scientific expertise and depth of regulatory knowledge allows us to foresee potential roadblocks in the supply chain so we can resolve issues in a timely and efficient manner, minimising risk while ensuring compliance. ​ CSI’s four guarantees of quality Timeliness of medicine supplies 1 Consistency and reliability of investigational medicines 2 Traceability throughout our supply chain 3 Comprehensive documentation and record-keeping 4 We operate with transparency and accountability, so you can always rely on our quality standards and operating procedures. Since documentation is often necessary for import and export purposes, all our products are delivered certified. Quality is in our DNA We understand that our robust standard operating procedures (SOPs) and quality-focused operations are as important to our success as our market knowledge, international networks and longstanding relationships with global suppliers and manufacturers. Our teams stay up to date with the latest regulatory developments across the globe and regularly implement changes necessary to stay compliant with the latest local government and regulatory agency requirements. We have stringent processes in place for our suppliers, manufacturers, authorised distributors and pharmaceutical wholesalers. We work directly with biopharmaceutical companies and have a long-established global network of over 100 audited suppliers spanning six continents, all of which maintain strict board requirements and guidelines from jurisdictions around the world to ensure regulatory compliance, quality and patient safety. Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit BI Dashboard | CSI Leads Status Website Performance & SEO LinkedIn page & Ads Performance Salesforce Overview Clinical Services International (CSI) | Case Studies CSI’s seamless comparator export to China Export of expensive comparators from Europe to China with first leg documents and streamlined approach Read more - - Learn More Rapid Oncology Study Supply How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline Read more Sourcing Flu Vaccines for a Global Trial 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 more Overcoming Drug Shortages How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read more - - Learn More Streamlining Biotechnology Supply Chains How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read more Oncology Product Batch Hunting How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read more Delivering Comparators for a Global Allergy Study 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 more - - Learn More 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 Read more - - Learn More Global CRO Oncology Partnership 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 more - - Learn More Delivering €1 million Savings for Pembrolizumab How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price Read more 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 Read more Global Device Distribution 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 more - - Learn More Case Studies CSI’s deep understanding of drug development means we can provide innovative solutions to supply global clinical trials, however complex. Learn how we do this below Our partners work tirelessly to improve patient outcomes and quality of life. At CSI we accelerate drug development by designing and delivering highly efficient and robust supply chains that allow our partners to deliver their clinical trials on time and budget. View All