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- Clinical Services International (CSI) | sustainability
CSI is EcoVadis certified, a global supply chain sustainability benchmark. Find out more about our commitment to ethical clinical trial supply procurement. Sustainability & Environmental, Social, Governance (ESG) to Modern Slavery Document We operate in a highly regulated industry, and we meet or exceed the highest standards of Environmental, Social and Governance (ESG) factors demanded by the MHRA. CSI is proud to have been given a Platinum Medal for Sustainability by EcoVadis , an award achieved by only the top 1% of more than half a million companies evaluated. We are proud of the diversity of our team: 67% of our workforce are women, we are multicultural, multi-faith, speak a dozen languages and celebrate and respect our differences. We have implemented wide-ranging initiatives to ensure fair and equitable treatment for all people and the inclusion of everyone. All of our facilities, including offices and warehouses, are contracted from best-in-class service providers, which we also select based on their ESG performance and commitment (e.g. they meet Class A standards). Our suppliers, including pharmaceutical and logistical companies, are primarily large multinational companies, which we also select based on their focus on sustainability. Our clients are primarily large, listed, global companies with clearly defined ESG policies and targets. APR 2024 Supplier Diversity Programme Our Supplier Diversity programme seeks diverse owned companies that can provide solutions complementary to the services we provide to our clients. We strive to work with suppliers that generate social and environmental impact when choosing the goods and services we purchase. A diverse supplier is a business that is at least 51% owned and operated by an individual or group that is part of a traditionally underrepresented or underserved group. We strongly prefer and encourage our suppliers to be certified by local, state, or third-party certification organizations. OUR MEMBERSHIPS We are proud corporate members of the following organization: WEConnect International UN Global Compact Our Diversity Programme May Include An ethnic or racial minority group Women (of any race or ethnicity) LGBTQ+ community Veterans or service-disabled veterans Persons with disabilities Cosmopolitan outlook Our green plan: an introduction The global climate crisis and air pollution levels constitute a public health emergency as both have serious consequences for individuals and communities, with disadvantaged and vulnerable populations being disproportionately affected, worsening health inequalities. In the United Kingdom, the Government, local authorities, and other legislative bodies are now increasingly focusing attention on this issue, and the Climate Change Act 2008 legally compels us to take action. Our green pledge CSI has been committed to a greener and more sustainable world since its inception in 2016, and we will continue to pursue our ambition to reduce the impact of our activities on the environment. This means that the way we operate today must meet the needs of the present, while collaboratively building on a cleaner and healthier environment for future generations. We also know that taking a sustainable approach will save money and deliver higher quality customer services. We will continue to embed this commitment to sustainable development within our organisation, maintaining a clear strategic focus and ensuring that our national and local sustainability responsibilities are firmly embedded in CSI’s overall strategy. CSI’s engagement strategy To inform our Green Plan, we listened to and engaged with our staff and stakeholders. As a result of our learnings, we have: 1 Created a Green Committee, consisting of a senior management task force and co-creation sessions, in which CSI staff are invited to share their ideas about sustainability and how our company can improve in this area 2 Retained EcoVadis to advise CSI on how to further improve our ESG strategy and help us to drive its implementation 3 Asked our non-executive directors to lead an independent oversight initiative Our green ambitions: What will we do? Reduce the carbon impact of travel and transport Reduce our use of energy, water and other resources Improve our estates and facilities Move to a model of sustainable procurement Design new models of innovation Reduce the carbon impact of travel and transport Reduce our use of energy, water and other resources Improve our estates and facilities Move to a model of sustainable procurement Design new models of innovation Our Green Ambitions: What will we do? Our corporate values Our corporate values underpin everything we do and will guide the development and delivery of our Green Plan. Our values are firmly embedded within our organisational culture. Honesty and integrity CSI upholds the highest ethics to comply with the regulations and procedures required in every aspect of our business Collaboration We aim to build long-term, lasting relationships with our clients and partners based on mutual trust and respect Pursuit of excellence We foster peer engagement, focus on employee ownership and empowerment, and are always striving for better Quality At CSI, quality is aligned with all of our strategic objectives and initiatives CSI’s corporate responsibility awards
- Clinical Services International (CSI) | Quality
CSI’s quality department provides regulatory expertise in global comparator sourcing and maintains the highest safety standards for clinical trial supplies. 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. CSI has a digitalized Quality Management System (QMS) through Simploud , a leading eQMS platform, 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. 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) Drug Supply Chain Security Act (DSCSA) 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 200 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
- Our Partners | Pharma & Biotech, CROs, Hospitals and Institutions
CSI is the trusted global partner of leading pharmaceutical and biotech companies, Clinical Research Organisations (CROs), hospitals and academic institutions. Our Partners Pharmaceutical and Biotechnology Companies Clinical Research Organisations (CROs) Hospitals and Academic Institutions The trusted global partner of leading pharmaceutical and biotechnology companies, Clinical Research Organisations (CROs), hospitals and academic institutions 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. Biotech Startups Agile clinical supply specialists The pace of early-stage biotech demands speed and discipline. Lean teams must hit clinical milestones while navigating scarce resources and a risk-averse funding climate. With global experience across first-in-human and early-phase studies, CSI designs and delivers end-to-end trial supply solutions that keep programmes compliant, on budget and on time. From sourcing and import-export to QA and release, we streamline the path to IND-CTA and beyond. What you get End-to-end trial supply planning built for lean teams Flexible procurement for limited batch sizes or niche molecules Regulatory intelligence to support IND-CTA submissions Access to a global network for rare and early-phase compounds Rapid-response logistics that adjust to protocol amendments or enrolment changes Learn more about our services The partner for first-in-human and beyond CSI empowers biotech innovators with fast, compliant and cost-efficient sourcing solutions - helping you reach first-in-human and beyond without compromising quality or timelines. Our expert team combines regulatory intelligence with a global sourcing network to secure niche molecules and manage limited batch sizes, while rapid-response logistics adapt to protocol changes and enrolment shifts. Mid-Size Pharma Companies Scalable clinical supply specialists Mid-size pharma must grow studies without growing risk. As clinical trials scale across countries, sites and protocols, you need compliant sourcing, tight cost control and simpler comparator and co-medication supply. CSI builds scalable, audit-ready clinical supply programmes that standardise processes, reduce vendor sprawl and keep budgets predictable. Through centralised procurement and global regulatory alignment, we streamline comparator and co-med sourcing, manage GDP and GxP-compliant cold chain logistics with end-to-end chain of custody, and coordinate import-export and QP release. Our team delivers batch-specific documentation and QA oversight, backed by proactive forecasting, scenario planning and real-time visibility to prevent stockouts and waste. The result is reliable multi-country trial supply that accelerates study start-up, protects quality and improves ROI for Phase II and III programmes. What you get Comparator sourcing expertise across therapeutic areas Optimised cold chain logistics with real-time tracking Batch-specific sourcing and documentation to meet QA requirements Tailored supply planning for regional or global trials Bridge supply support between phases or protocol changes Learn more about our services Reliable supply for multi-country studies CSI is your strategic partner for scaling clinical operations with confidence - offering transparent pricing, regulatory alignment, and reliable supply for multi-country studies. We combine deep comparator expertise across therapeutic areas with optimised cold chain and real-time tracking. Batch-specific sourcing and documentation meet QA needs, while tailored plans support regional or global designs and maintain bridge supply through phase transitions or protocol changes. Pharmaceutical and Biotechnology Companies Global trial logistics specialists The globalisation of clinical trials requires country-specific regulatory expertise. Pharmaceutical and biotech companies must be able to understand changes around international drug sourcing and import and export requirements to remain compliant. With global experience spanning six continents, CSI provides targeted solutions to serve trials worldwide, sourcing and supplying medicines, medical devices and ancillaries to Europe, the United States, Central and South America, and Asia-Pacific. It has been very beneficial working with the CSI team. They have excellent scientific expertise, clearly understood the challenge, and provided outstanding solutions. Their global reach allowed us to tap into many markets. They are customer-focused, result-driven, and we enjoyed working with them. Well done, Team! Director of Drug Product, Formulation & Stability at a leading gene therapy Biotechnology company Learn more about our services The gold standard for the clinical trial supply Pharmaceutical and biotechnology companies are increasingly facing pressure to move candidates through the clinical trial pipeline quickly. Greater need for efficiency requires an expert comparator sourcing and supply chain partner that can alleviate disruptions to timelines, costs and product availability. CSI helps to grow trial pipelines and optimise trial performance. We are a proud supplier to top-ten pharmaceutical companies and leading biotechs. Reducing risk, boosting success CSI reduces risk across every part of the supply chain, boosting trial success rates by ensuring delivery of the right comparator drugs, devices and services at the right place and time, even for the most complex adaptive clinical trials. Clinical Research Organizations (CROs) Managing the entire supply chain CSI manages the entire supply chain, allowing CROs to concentrate on finding patients and delivering successful trials. Our seamless supply management operations and distribution solutions ensure CROs can operate efficiently, saving time, money and resources. Six areas of expertise drive CSI’s ability to effectively source comparators, medical devices and ancillaries: Protocol interpretation Product access Supply continuity Cost control Speed Supporting documents A truly global footprint Our CRO partners conduct studies all over the world. CSI’s strong global presence and expertise means we can support even the most complex studies and clinical supply requirements. With warehouses in more than 50 countries, we can efficiently and consistently provide solutions across Europe, the United States, Central and South America, and Asia-Pacific. The science of clinical trial supply CSI provides secure and transparent sourcing of products for a broad range of clinical trials across all therapeutic indications. With decades of combined experience in drug development, our team provides fully integrated, one-stop solutions. We pride ourselves on our ability to assist our partners with comparator identification, strategic guidance around the protocol, and cross-market regulatory advice. Expertise you can rely on Clinical trial supply chains require robust planning and management to ensure successful, reliable delivery. We provide regular forecasts to optimise timelines, ensure quality, maintain safety, comply with security standards, and remain on budget. Quality is in our DNA With longstanding relationships with MHRA and EMA, CSI’s regulatory and quality assurance experts provide expert advice. All our teams stay up to date with the latest government and agency requirements around the world, while our country-specific regulatory expertise minimises risk and guarantees compliance. CSI are Drug Supply Chain Security Act (DSCSA) complaint and has a digitalized Quality Management System (QMS) Simploud , a leading eQMS platform, for the convenience of our clients. Integrated clinical supply specialists CROs need dependable clinical trial supply partners that plug into sponsor timelines without friction. As full-service proposals grow, adding consistent, audit-ready supply capabilities helps you win bids and deliver with confidence. CSI operates as an extension of your project team, aligning with PMO workflows, governance and quality systems. We handle comparator and co-medication sourcing, ancillary supply, GDP-compliant cold chain logistics, import-export and site enablement to keep visits on schedule and patients on drug. What you get White-label or collaborative partnerships to support CRO bids Rapid sourcing feasibility for sponsor RFPs Regulatory-compliant supply documentation for audit readiness Global reach to support diverse sponsor geographies Dedicated account team aligned with CRO project managers Learn more about our services A responsive partner that enhances CRO delivery As a responsive and agile supply chain partner, CSI enhances CRO delivery by managing complex sourcing and logistics with precision - so your clients stay focused on patient outcomes. We support white-label or co-branded engagement models, provide rapid sourcing feasibility for sponsor RFPs, and produce regulatory-compliant documentation to maintain audit readiness. With global reach and a dedicated account team aligned to your project managers, we reduce supplier sprawl, accelerate start-up and keep study costs predictable. Hospitals and Academic Institutions Adding value from the outset By partnering with hospitals and research centres at an early stage of their studies, CSI can comprehensively assess clinical trial requirements from the outset, providing strategic solutions and utilising our extensive sourcing expertise. As a dedicated sourcing solution provider, CSI streamlines the entire procurement process, allowing researchers and healthcare professionals to focus on their core activities. We take on the extra burden We supply a diverse range of medications, comedications, ancillary products – such as lab kits, clinical site files and test tubes – and provide a printing service. This relieves our partners of administrative burdens, allowing them to focus their resources on trial patient recruitment. Handling every aspect of trial supply While Clinical Research Associates (CRAs) handle site qualification, CSI takes charge of assessing the study protocol and providing the necessary trial support services: Calculating product quantities Negotiating competitive pricing Coordinating delivery schedules Managing inventory levels Minimising supply shortages and wastage Your partner for cutting-edge research CSI works closely with world-class academic institutions, universities, hospitals and research centres that are producing cutting-edge medical research. We support their clinical trials by providing a wide range of cost-effective and compliant comparator medicines and ancillaries. A history of working together CSI’s Managing Director, Vanessa Dekou , is on the advisory board of Chelsea and Westminster Hospital in London and UCL's Global Business Schoolfor Health . CSI also has a history of close collaboration with University College London, providing internship and career opportunities following Vanessa’s own studies there. Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit
- Clinical Services International (CSI) | Oncology Products
CSI specialises in supplying oncology products to global clinical trials all over the world, from generics to the most sophisticated cold chain biologics. The front line of research and clinical trials CSI specialises in supplying oncology products to clinical trials all over the world. Treatments for cancer have been advancing at an accelerated pace in recent years, resulting in significant clinical benefits and increased specificity through selection according to biomarkers or through engineered cell or gene therapies. Innovation is in our DNA, and we want to be part of your journey, helping you to advance your studies and improve patient outcomes with our clinical trial supply expertise. Oncology Products Oncology product sourcing specialists CSI has supplied oncology products to more than 1000 studies – from generics to the most sophisticated cold chain biologics. 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 Ruxolitinib 25+ 2, 3 Global Biologic Number of Studies Phase of Trial Geography Keytruda (pembrolizumab) 50+ 1, 2, 3 Europe, USA Eylea (aflibercept) 50+ 1, 2, 3 Europe, USA, Latin America Opdivo (nivolumab) 50+ 1, 2, 3 Global Yervoy (ipilimumab) 50+ 1, 2, 3 Global Jakavi (ruxolitinib) 25+ 2, 3 Global Biologic Number of Studies Phase of Trial Geography CSI specialises in supplying oncology products to clinical trials all over the world. Treatments for cancer have been advancing at an accelerated pace in recent years, resulting in significant clinical benefits and increased specificity through selection according to biomarkers or through engineered cell or gene therapies. Innovation is in our DNA, and we want to be part of your journey, helping you to advance your studies and improve patient outcomes with our clinical trial supply expertise. Case Study Oncology Product Batch Hunting How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Medicine Keytruda (pembrolizumab Eylea (aflibercept) Opdivo (nivolumab) Yervoy (ipilimumab) Jakavi (ruxolitinib) Number of Studies 50+ 50+ 50+ 50+ 25+ Phase of Trial 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3 2, 3 Geography Europe, USA Europe, USA, Latin America Global Global Global 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 Outcome CSI’s high level of market knowledge resulted in the successful delivery of the required product and ensured the client’s trial never ran dry Solution We worked closely with suppliers to hunt specific batches in several European markets where batch visibility and documentation were possible We know our science There are many different types of targeted cancer drugs. These are categorised depending on how they work. Some drugs belong to more than one group because they work in more than one way. For example, a drug that works by blocking cancer cell growth may also be a monoclonal antibody. Some of these targeted drugs might also be called immunotherapies or biological therapies. Monoclonal Antibodies (MABs) Monoclonal antibodies (MABs) are a type of targeted drug therapy. They work by recognising and targeting specific proteins on cancer cells. There are many different MABs to treat cancer, and they work in different ways to kill the cancer cell or stop it from growing. Pertuzumab a treatment for breast cancer Bevacizumab a treatment for a number of different cancer types Rituximab a treatment for chronic lymphocytic leukaemia (CLL) and some types of non-Hodgkin lymphoma Cetuximab a treatment for advanced bowel cancer, and head and neck cancer Trastuzumab used to treat breast cancer and stomach cancer Ipilimumab and Nivolumab used together to treat a number of different cancer types Some MABs help the immune system to attack and kill cancer cells, so they are also a type of immunotherapy. Cancer Growth Blockers Cancer growth blockers are also called cancer growth inhibitors, and there are many different types. Our body makes chemicals called growth factors that control cell growth. Cancer growth blockers work by blocking the growth factors that trigger cancer cells to divide and grow. controls cell growth Epidermal growth factor (EGF) controls blood vessel development Vascular endothelial growth factor (VEGF) controls blood vessel development and cell growth Platelet derived endothelial growth factor (PDGF) controls cell growth Fibroblast growth factor (FGF) olaparib (Lynparza) rucaparib (Rubraca) niraparib (Zejula) PARP Inhibitors PARP inhibitors can be used to treat ovarian cancer and are currently in clinical trials for treatment of other types of cancer. PARP (poly-ADP ribose polymerase) is a protein found in our cells that helps damaged cells to repair themselves. As a cancer treatment, PARP inhibitors stop the PARP from repairing cancer cells, so the cell dies. Olaparib Rucaparib Niraparib Drugs that block blood vessel growth factor Some anti-angiogenics prevent vascular endothelial growth factor (VEGF) from attaching to the receptors on the cells that line the blood vessels. This stops the blood vessels from growing. One drug that blocks VEGF is bevacizumab (Avastin), which is also a monoclonal antibody. It is a treatment for several different types of cancer. Bevacizumab Aflibercept Ramucirumab Anti-Angiogenics Anti-angiogenic drugs are treatments that stop cancer tumours from growing their own blood vessels, slowing their growth and sometimes shrinking them. There are different types of anti-angiogenic drugs, which work in different ways. Checkpoint Inhibitors Checkpoint inhibitors are a type of immunotherapy. They are a treatment for cancers such as melanoma skin cancer and lung cancer. These drugs block different checkpoint proteins. You might also hear them named after these checkpoint proteins: CTLA-4 inhibitors, PD-1 inhibitors and PD-L1 inhibitors. Pembrolizumab Ipilimumab Nivolumab Atezolizumab Avelumab Advances in cancer therapeutics Over the past five years, 61 cancer drugs, each approved in one or more tumours, have impacted the treatment of 23 different cancer types. The rise of immuno-oncology since 2014 has been largely centred on the PD-1 and PD-L1 mechanisms – so-called checkpoint inhibitors – which have broad efficacy across solid tumours and are used across 23 different tumour types. The range of clinical benefits from this new group of medicines includes several with total remission rates above 50% and significant extensions of overall survival, as well as some with incremental survival benefits in tumours where those rates were already extremely high. Monoclonal Antibodies (MABs) Monoclonal antibodies (MABs) are a type of targeted drug therapy. They work by recognising and targeting specific proteins on cancer cells. There are many different MABs to treat cancer, and they work in different ways to kill the cancer cell or stop it from growing. Pipeline for clinical development More than 1000 cancer drugs are in late-stage development – up over 60% from a decade ago. Over one third of these clinical trials are using biomarkers to stratify patients, pointing to even more personalised and effective cancer treatments in the future. At CSI, we design supply chains to minimise wastage and ensure sites have the medication they need, precisely when they need it. We proactively manage your study’s supplies and can deliver significant savings. Axitinib Dasatinib Erlotinib Imatinib Nilotinib Pazopanib Sunitinib Bortezomib Drugs that block signalling within the cell Some drugs stop the VEGF receptors from sending growth signals into the blood vessel cells. These treatments are also called cancer growth blockers or tyrosine kinase inhibitors (TKIs). Sunitinib Sorafenib Axitinib Regorafenib Cabozantinib Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit
- Modern Slavery Document | CSI
Read CSI’s Modern Slavery Statement outlining our commitment to ethical supply chains and responsible operations across our network.
- Job Application Form | CSI
Job application form First name* Last name* Email* Phone* Position* Address* LinkedIn URL * Portfolio or website URL Upload CV* Upload File Message Submit
- Book a Meeting With Yasmine Clemson | CSI v1
Available online Meeting with Yasmine
- Clinical Services International (CSI) | Medical Devices and Ancillaries
Reliable sourcing and logistics for medical devices and ancillaries for trials, from equipment to print materials, with cost effective delivery and managed returns. As well as medications, clinical trials often require a wide variety of ancillary supplies. These include medical and technological equipment such as weighing scales, pill cutters and electrodes, disposable products, lab kits and print materials such as site files and pharmacy binders. At CSI, we apply our sourcing capabilities, logistical expertise and robust quality standards to ensure that all essential supplies reach trial sites in a reliable and cost-effective manner, no matter their location. We also handle the returns process, so that once a site or patient has completed the trial, all materials are sent back to the warehouses. Leveraging our partnerships with leading manufacturers, we can offer significant cost savings on ancillaries to support our partners’ clinical trials. Download our brochure to find out all of our comprehensive ancillaries services. Medical Devices and Ancillaries Download PDF Up to 60% on initial shipments Up to 40% on resupply shipments Up to 60% on broker fees (customs clearance) Case Study CSI’s ancillary services include the rapid delivery of Medical equipment Electrocardiogram (ECG) tests Spirometers Weighing scales Blood pressure monitors Infusion pumps Cooled or uncooled centrifuges Refrigerators Freezers with temperatures ranging from -20°C to -80°C Technological equipment eDiaries Mobile devices Laptops Printers Pill splitters Print materials Investigator site files Pharmacy binders Patient recruitment material Download our Ancillaires brochure
- Clinical Services International (CSI) | Case Studies
CSI case studies show how we deliver global clinical trial supplies - comparators, devices, and ancillaries - on time, in budget, and fully compliant Case Studies CSI’s expertise in drug development means we can provide innovative solutions to supply global clinical trials, however complex. Learn how we do this below. 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. Filter: Therapeutic Area/Phase Select to filter: Supply Challenge/Characteristics Select to filter: Comparator Product Select to filter: Effective Sourcing of Semaglutide for a Global Phase III Clinical Trial Ensuring batch-consistent, compliant comparator supply across NA, EU, and APAC - on time and uninterrupted. Read More CSI's 72-hour Abraxane Rescue Mission From supply shortfall to on-time first-patient-first-visit across Europe, delivered in three days. Read More CSI’s Expert Delivery of a Global Respiratory Study Adaptive, multi-product supply across 22 countries and 80 sites, kept on time, in budget and compliant. Read More Rapid Sourcing of Discontinued Southern Hemisphere Vaccine for a Global Biopharmaceutical Client A leading global biopharmaceutical company urgently requested CSI to supply the Fluarix QIV Southern Hemisphere Vaccine for 2025. Read More Securing Long-Term, Cost-Effective Supply of Eylea EU & USA for programs of studies Securing reliable, cost-effective, long-term supply of Eylea PFS from EU and USA for a global biotech company’s clinical studies. Read More Comparator Sourcing for a Phase II Ophthalmology Study A biotech client asked CSI to source Lucentis for a Phase II ophthalmology trial. Read More How CSI streamlined Venetoclax and Azacitidine supply across 17 countries in record time CSI Efficiently Delivered Venetoclax and Azacitidine Across 17 Countries Read More CSI’s seamless comparator export to China Export of expensive comparators from Europe to China with first leg documents and streamlined approach 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 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 Rescuing a Biotech’s Oncology Trial with Lenvima How CSI fulfilled what our competitors couldn’t: rapidly sourcing oncology medication from the EU for a trial in South Korea Read 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 Global Jakavi Study How CSI supplied large quantities of Jakavi to a Biotech’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read 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 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 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 Rapid Eylea Study Supply How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s study within a tight deadline Read More Streamlining a Biotech's Supply Chain with local sourcing How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial 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 found 20 results Golf
- Clinical Services International (CSI) | Privacy Policy
This Policy serves to outline the aspects of General Data Protection Regulation (GDPR) relevant to CSI’s operation and ensure CSI complies with legislation. Purpose This Policy serves to outline the aspects of General Data Protection Regulation (GDPR) relevant to CSI’s operation and ensure CSI complies with legislation. Scope This Policy applies to all CSI employees at all times when collecting, handling, or processing personal data in any format. Responsibilities Applies to all CSI employees when handling private data. Definitions and Abbreviations · GDPR – General Data Protection Regulation · Personal data – Data that can identify an individual (e.g. name, address, email, National Insurance Number, bank details) · SME – Small and Medium-sized Enterprises (companies with less than 250 employees) References General Data Protection Regulation GDPR rules for businesses and organisations Policy With the coming into force of the GDPR law as of 25 May 2018, companies now have certain obligations in relation to collecting, processing and storing personal information. In the context of its current activities, CSI does not collect or store any data about patients, including patient personal details. However, CSI does collect, process and store personal data in the form of contact details of suppliers, clients and other entities for the purpose of carrying out its business and operational activities. Justification for collecting, processing, and storing Any personal data collected, processed or stored must be justified (i.e. it must have a justifiable purpose). There are three types of justification: · Legal Obligation – The personal data is required in order to fulfil a CSI Legal Obligation. This category would include CVs of employees kept on file for compliance with GDP/GMP requirements. This also applies when keeping certain records on file which may contain personal data (e.g. email addresses), such as shipment records kept on file for seven years. · Contractual – The personal data is required to fulfil CSI’s contractual obligations. This includes CSI collecting personal information about its employees to manage payments and pensions; all business contacts with existing suppliers and clients; and the contacts of third-party entities that CSI is required to involve in order to fulfil its contracts (e.g. the client providing the contact person at their appointed depot). · Legitimate Interest – This is personal data that CSI has a legitimate interest in. Examples include contacts of prospective clients, suppliers and other potential business partners, and the personal details of candidates for CSI job vacancies. Personal data that cannot be justified by any of the categories above should not be collected, processed, or kept by CSI. For further details of our Policy, please contact info@csint.com . Privacy Policy
- Clinical Services International (CSI) | Project Management
Dedicated project management for clinical trial supplies with 25 years of expertise, proactive risk control, and QP certified regulatory support to keep studies on track. We have never failed to deliver to a study CSI has over 25 years of experience in developing effective comparator sourcing strategies. We use our expertise to successfully plan and manage the entire sourcing supply chain, helping to simplify the supply process, minimise risk and maximise cost savings for our partners. With our service-orientated approach, our partners benefit from a dedicated relationship person and ongoing support and problem solving at every stage of a project. There are many moving parts and unpredictable factors at play in clinical supply chains. With CSI’s specialist project management and logistical expertise, we understand the complexities involved in planning and managing clinical trial supplies and strive to mitigate any risks that might prevent our pharmaceutical, biotechnology and CRO partners from operating at maximum efficiency. Project Management Protocol and market analysis “A scientific approach to clinical trial supply” An effective clinical supply management strategy begins with the comprehensive understanding of a trial protocol. This is where CSI’s 25 years of scientific expertise sets us apart from other clinical trial supply companies, allowing us to provide the best possible advice on the most efficient and cost-effective sourcing strategy for any study. Analysing trial-specific factors such as the required medications, ancillaries, quantities, locations, documentation, timeframes and the availability of generics, allows CSI to present an optimised local, central, market, manufacturer, wholesaler or hybrid sourcing strategy. With experience of shipping to even the most remote countries around the world, we offer expert regulatory guidance, can anticipate global supply challenges, and develop custom supply solutions for our partners. Case Study Supply planning and risk management An effective comparator sourcing strategy requires robust forecasting to maximise supply chain efficiency and minimise potential costs for all parties. Thorough forecasting involves identifying the potential risks that might arise at each phase of a trial – including fast or slow patient recruitment; availability, expiry and batch requirements of a medication; potential drug shortages or fluctuations in global market price and demand – and the impact these might have on the clinical supply chain, before ensuring that necessary contingency measures are in place to protect budgets, timelines and, ultimately, trial data. CSI’s six steps for effective risk management Identify Evaluate Control Communicate Review Report Qualified Person and regulatory services All Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a clinical trial. CSI’s respected and well-established quality department has in-depth experience across a wide range of product types and dosage forms, and ensures regulatory compliance across all of our international operations. 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 MHRA and EMA and can provide advice and solutions for our partners’ clinical trial supply needs. Since documentation is often necessary for import and export purposes, all our products are delivered certified. 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, while the depth of our regulatory knowledge allows us to foresee potential roadblocks in the supply chain so we can resolve issues in a timely and efficient manner. Visit our Quality page
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