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Blog Posts (82)

  • 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 International (CSI) achieved the Platinum EcoVadis award, scoring in the Top 1% of companies rated for categories ‘Environment’, 'Labour & Human Rights', 'Sustainable Procurement' and 'Ethics', showing our commitment to a greener future in clinical trial supply. ESG stands for Environmental, Social, and Governance and is a framework used to evaluate and measure the sustainability and societal impact of a company. 🌳Environmental: This aspect focuses on how a company performs in terms of its impact on the environment. It includes factors such as carbon emissions, energy efficiency, waste management and resource conservation. CSI launched the robust Green Plan program in December 2022 to provide clear guidance that creating a greener environment is a key responsibility to minimize negative impacts on the environment on all 5 key aspects below: 🚮Waste reduction 🛒Sustainable Procurement ✈️Carbon emissions 💡Energy efficiency 🌿Resource conservation We work diligently with our partners at each stage of the clinical supply chain to share and implement best sustainable practices. 🧑‍🤝‍🧑 Social: This aspect assesses how a company manages its relationships with employees, clients, suppliers, and the communities in which it operates. Social factors include: ✅Labour practices ✅Diversity and inclusion ✅Human rights and ethics ✅Community support ✅Safety CSI ensures that every step of our clinical trial supply chain is environmentally conscious, socially responsible and governed with integrity. This begins with supporting six local and global charities and focusing on the training and wellbeing of our staff. Integrating social considerations alongside environmental and governance factors is essential for building trust, promoting sustainability and advancing responsible clinical trial supply chain practices. 💼 Governance: This aspect examines the quality of a company's corporate governance structure and practices. In the context of clinical trial supply chains, the 'Governance' aspect of ESG (Environmental, Social, and Governance) refers to the policies, procedures, and structures in place to ensure that ethical principles, regulatory requirements, and industry standards are upheld throughout the clinical trial supply process. Our policies include, but are not limited to: 💠 Supplier Diversity Programme 💠Environmental and Sustainability Policy 💠Corporate Social Responsibility (CSR) Policy 💠Modern slavery Policy 💠Equality and Diversity Policy 💠Anti-corruption Guidelines 💠Sustainable Procurement Policy 💠Human Rights Policy By prioritizing governance principles alongside environmental and social considerations, organizations can promote responsible and sustainable clinical research practices.

  • 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 Plus Team Thirty at Thirty appeal at Mansion House. Patient care is at the centre of what we do at CSI and it was an honour to be a part of this charity fundraising event, in aid of our local hospital. New Cancer and Renal Disease centres are underway. To find out more and donate, follow the link: https://www.cwplus.org.uk/adc/V

  • 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 performance. This prestigious certificate is awarded to companies that demonstrate outstanding sustainability practices across environmental, social, and ethical governance. Achieving the Ecovadis Platinum award confirms that CSI has excelled in sustainability performance evaluation, surpassing industry standards. This award reflects our commitment to sustainable business practices and responsible corporate citizenship. Contact CSI, your platinum clinical trial supply partner.

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  • Our Partners | Pharma & Biotech, CROs, Hospitals and Institutions

    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. Pharmaceutical and Biotechnology Companies 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. 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. Clinical Research Organisations (CROs) 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. 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. Hospitals and Academic Institutions 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 the Judge Business School at the University of Cambridge. CSI also has a history of close collaboration with University College London, providing internship and career opportunities following Vanessa’s own studies there. 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. Our Partners Pharmaceutical and Biotechnology Companies Clinical Research Organisations (CROs) Hospitals and Academic Institutions Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Contact us Submit Company type

  • Clinical Services International (CSI) | Job openings

    Designated Representative / Facility Manager Location: Horsham (PA), United States Clinical Services International is a global leader of pharmaceutical products and services for clinical trials. We do Intelligent Sourcing of medicines, Generics, Diagnostics and Medical Devices throughout the world, supplying the clinical trials that develop tomorrow’s medicines. ​ We manage the entire supply chain and offer tailor-made solution for clinical trials. We have grown very significantly, and we are now looking to appoint a Designated Representative / Facility Manager in our warehouse/office in Horsham (PA), USA Apply Now Responsibilities Take responsibility and act as the point of contact for Federal and State regulatory compliance, and communication from the Federal and State agencies. Ensure operations adhere to Federal and State regulations as well as CSI’s Standard Operating Procedures (SOPs) and Policies. Maintain awareness and understanding of all applicable Federal and State regulations and provide updates to the global organisation for awareness and compliance. Drive the effort to obtain licenses in multiple states across the continental United States (US), as directed by CSI’s strategic plan. Ensure that internal controls are in place and that appropriate corrective and preventive measures are implemented collaborating with the Global Quality Assurance Manager (GQAM). Provide support and act as directed by the GQAM to ensure the efficient and effective operation of the Quality Management Systems (QMS) Lead and/or participate in regulatory and client audits. Provide technical and quality system support to the wider business. Ensure that operations do not compromise the quality of medicines. Ensure that adequate records are maintained as per Code of Federal Regulations (CFR) requirements. Be the contact for recalls in the US, supervise recalls and confirm the completion of all activities associated with the recall as defined in CSI procedures and Federal requirements. Ensure customer complaints are dealt with efficiently and effectively. Ensure the final disposition of returned, rejected, recalled or falsified products are handled diligently and in compliance with current regulatory requirements. Ensure that additional requirements imposed on certain products by State law are adhered to. Follow the entire order lifecycle: serve as a regular point of contact with clients supervising procurement of goods, logistics and delivery to the client. Pro-actively communicate the project status to all stakeholders and actively ensuring on-time project delivery. Coordinate workflows with various service providers to fulfil complex projects in a timely manner with maximum client satisfaction. Identify and proactively resolve order-related discrepancies from a quality and financial perspective. Coordinate processes with logistics service providers: depots, carriers, customs agents and relabelling / repackaging providers Using a combination of your own initiative and management direction, work towards the elimination of operational concerns taking a continuous improvement approach to minimise risk and improve processes. Comply with all CSI Global Procedures, Policies and Local SOPs. Efficiently report, investigate and resolve quality incidents and liaise with suppliers, clients, depots and carriers as required. Completion of other responsibilities as delegated by the Director of Strategy and Business Development and/or the Global Quality Department Job Description Reporting to the Director of Strategy and Business Development, you will be our Designated Representative, directly responsible for our operations in the US, as well as having oversight and relationship responsibilities for certain American clients. ​ As per State requirements for a Designated Representative, this position requires the successful applicant to be present on site for 5 days a week in our facility in Horsham (PA). There is no scope for hybrid or fully remote candidates. ​ Person Specification ​ At least 3 years experience within the pharmaceutical industry (Essential) knowledgeable of the FDA and state requirements for Wholesale Dealers (Essential) Degree in a scientific discipline (such as Biology, Pharmacy, Chemistry etc.) (Essential) Able to attend the Horsham (PA) site 5-days a week (Essential) Project Management / Account Management experience (Desired) Logistics / Warehouse operations experience (Desired) ​ A critical component of this role requires you to be familiar with, aware of and responsible for the company’s legend (prescription) drugs and/or device business, including writing and ensuring adherence to policies and procedures, storage, security, temperature control, inventory counts, pick/pack and shipping operations, customer returns, and recalls. ​​ ​​ In return we offer: An amazing opportunity to contribute to a fast growing, pharmaceutical company. A 'can do' culture where you will be encouraged to get involved in a range of exciting initiatives and to introduce new ideas ​ The opportunity to learn new skills and ongoing personal development and career opportunities ​ What’s in for you? ​ Career Progression: You will be able to develop your career with a wide variety of opportunities and work with highly experience people in the industry. From continuing your professional development in clinical services, to engaging with Blue Chip Pharmaceutical clients all over the world. Develop scientific knowledge and expertise in clinical trials and drug development. ​ Package: ​ Competitive salary dependent on experience, annual leave, bonus structure, Pension Scheme, great working environment. ​ Location: Facility Based, Horsham (PA), USA. ​ Apply Now Apply Now

  • Case Study | Rescuing a Global Biotech's Oncology Study with Cetuximab

    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 CRO 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 CRO 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

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