As we prepare for Q1 2026, sponsors and CROs face a shifting global landscape for clinical trial comparator sourcing that focuses on sustainability, diversity and fair pricing. With our EcoVadis Platinum certification, women-owned business status and full scientific team in place, CSI is well placed to support our partner’s supply chains. 1. Supply-chain volatility is real Clinical supplies are increasingly challenged by geo-political pressures, export controls, and manufacturing concentration. Add to that evolving regulatory expectations (global CoA requirements, tighter comparator traceability), and sponsors need a partner with well-established manufacturer relationships. CSI’s direct accounts with major manufacturers puts us in a strong position to support complex comparator supply and to help you meet critical timelines. 2. Regulatory and pricing policy shifts are reshaping the industry In the US, Donald Trump’s administration has renewed focus on the “most-favoured nation” (MFN) pricing model: tying US drug prices to those paid in other comparable countries . For example, a landmark deal between Pfizer and the US Government commits to aligning US prices with developed‐world benchmarks and expanding domestic manufacturing. What does this mean for trial sponsors? Branded comparator supply may become subject to pricing/launch shifts; companies may delay or reprioritize markets to protect pricing globally. Demand for transparency, documentation and supply reliability will increase for all parties to manage risk. Suppliers who can offer robust supply assurance, global-ready documentation and diversified sourcing will gain an advantage. 3. Why this matters for your 2026 pipeline With pipeline activity increasing (NMEs, ATMPs, biosimilars) and sponsors under timer pressure, the comparator sourcing window is tightening. A partner who can deliver import/export guidance, traceability and contingency planning is critical. At CSI we combine: End-to-end comparator supply support Global documentation (including via our certified scientific team) Sustainability, ethical sourcing and a women-owned organisational profile that meets many corporate supplier diversity mandates Direct manufacturer access to cut out unnecessary middle-men and reduce lead-times 4. Actionable next steps for sponsors Audit your comparator sourcing providers now : Do your current partners adhere to lead times and regulatory documentation requirements? Ask your comparator supplier : Can they guarantee CoAs for every shipment, global registration‐ready documentation and alternative supply routes if challenges such as shortages arise? Consider regulatory/policy headwinds : The evolving US pricing environment means some branded drugs may face launch delays or pricing adjustments. Factor this into your comparator selection discussions. Partner with a supplier who understands both science and logistics : From molecule sourcing to clinical packaging, CSI can overcome these complexities. At CSI, we are ready to support your study needs, whether global or US, novel comparator or established branded. With our SAM.gov and BARDA approvals, women-owned status, EcoVadis Platinum certification and full scientific team, you get a partner who understands the end-to-end challenges and can act as your supply-chain ally. Ready to map your comparator strategy for 2026? Try us out for a quote.

Oncology products monopolise the list of best-selling drugs. With a huge range of indications that is only growing, therapies become more specific to tumour or cell pathologies and increasing patient numbers. Several oncology products now have ‘blockbuster’ status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. A significant proportion of the late-stage clinical trial pipeline is in oncology indications as immunotherapies and next-generation biotherapeutics are gearing up for approval. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often. Keytruda (Pembrolizumab) and Opdivo (Nivolumab) Number 2 and number 11 respectively in annual sales of oncology products are Merck’s Keytruda ($7.2B) and BMS’s Opdivo ($1.8B) . They are both checkpoint inhibitors targeted towards Programmed cell Death protein 1 (PD-1 inhibitors) that is responsible for downregulating the immune system that prevents the immune system from killing cancer cells. As both products target the same pathway, they naturally compete in many indications (Table 1). Keytruda Opdivo ​Melanoma Melanoma (in combination with Yervoy) Non-small cell lung cancer (as monotherapy and combination) Non-small cell lung cancer Urothelial carcinoma Urothelial carcinoma Classical Hodgkin lymphoma Classical Hodgkin lymphoma Head and neck squamous cell carcinoma Squamous cell cancer of the head and neck ​ Advanced renal cell carcinoma (in combination with Yervoy) Table 1: Indications for Keytruda and Opdivo. This means for many therapies, it is the physician’s choice whether to use Opdivo (often in combination with Yervoy) or Keytruda. Keytruda has been more successful in part due to its higher efficacy among all groups and reduced toxicity. Both of these products are incredibly popular in clinical trials; a search on clinicaltrials.gov shows that there are 783 studies recruiting using Keytruda and 707 for Opdivo. Herceptin (Trastuzumab) and Mabthera (Rituximab) Roche’s Herceptin and Mabthera come in at number 3 and 5, selling $7B and $6.8B respectively. They are highly effective therapies for HER-2 positive breast cancer (Herceptin) and Non-Hodgkin’s Lymphoma (Mabthera), two of the most common and widely treated cancers. However, the financial success of these products is under threat. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g. Celltrion’s Herceptin biosimilar – Truxima). As more trials show equivalency in outcomes between the branded and biosimilar product, more purchasers will choose the cheaper option. On clinicaltrials.gov , there are 246 recruiting studies with Trastuzumab and 415 with Rituximab; a growing proportion of them will choose the biosimilar. No product is safe from the encroachment of biosimilars, #4 (Roche’s Avastin – $6.8B) is also under threat as Amgen’s Mvasi has been approved by the Food and Drug Administration (FDA). As these blockbuster products continue to increase their market share and more trials are running globally utilising these products, sourcing them has become a hugely important part of a successful clinical trial. All the products mentioned come at a significant cost, running into the thousands per dose. It makes sense then to partner with an expert in sourcing to ensure the most efficient, risk-free, and cost-effective solution possible. Clinical Services International is a trusted partner of leading Pharmaceutical and Biotechnology Companies, Clinical Research Organisations, and Contract Manufacturing Organisations. We are experts in sourcing licensed and unlicensed medicines for use in trials, ranging from eye drops to the most sought-after blockbuster therapies.

Clinical trials are the backbone of medical advancement, providing the essential data to bring new therapies from the laboratory to the clinic. However, the complexities and costs associated with clinical trial supplies have been rising, making it challenging for many organizations to navigate the process effectively. Outsourcing has emerged as a strategy for managing these sourcing challenges and driving success in clinical trials. Here’s how to leverage outsourcing to ensure your clinical trials are successful. 1. Understanding the Need for Outsourcing Clinical trials involve multiple stages, each with unique requirements that demand specialised knowledge of markets and resources. These stages include protocol analysis, product sourcing, manufacturing and distributing. By outsourcing, Pharma and Biotech's can access expertise that may not be available in-house, reduce operational costs, and focus on core competencies.   2. Choosing the Right Partners The success of outsourcing in clinical trials hinges on selecting the right partners. Clinical Research Organizations (CROs) and specialized solutions providers are among the typical partners. Here are key factors to consider when choosing outsourcing partners: Experience and Expertise : Look for partners with a proven track record in your therapeutic area. CSI has successfully supplied more than 1000 trials worldwide and we have the most comprehensive knowledge in oncology supplies. In addition, direct accounts with more than 95 pharmaceutical companies and a network of warehouses in 60 countries enables us to deliver the most demanding adaptive trial. Regulatory Knowledge : Ensure they have a deep understanding of the regulatory landscape in the regions where your trials will be conducted. CSI has outstanding regulatory expertise in-house and has conducted trials across 45 countries in Europe, North and South America and Asia. Cultural Fit and Communication : Effective collaboration requires partners who align with your organisational culture and communication style. CSI has recently been awarded the Platinum EcoVadis Award, highlighting our commitment to a sustainable and ethical future in clinical trials. 3. Defining Clear Objectives and Expectations Clear objectives and expectations are crucial for any outsourcing relationship, by defining the scope of work, timelines, deliverables and quality standards from the outset. CSI develops comprehensive contracts to formalize these expectations and ensure accountability. 4. Maintaining Oversight and Quality Control While outsourcing can offload significant work, maintaining oversight is essential. CSI establishes regular communication via bi-weekly meetings to monitor progress and address any potential issues promptly and manages performance against well-defined KPIs, mutually agreed 5. Leveraging Technology Technology can enhance the efficiency and effectiveness of outsourced clinical trials. CSI invests heavily in research and has several extensive in-house database systems that enable us to monitor all regulatory requirements all over the world and can proactively offer solutions to our clients.     6. Fostering Long-term Relationships Building long-term relationships with outsourcing partners can provide ongoing benefits, such as enhanced trust, better collaboration and improved efficiency in future projects. Investing in these relationships can lead to more seamless integration and a deeper understanding of each party’s requirements and priorities.     Conclusion When executed strategically, outsourcing is a powerful tool to drive success in the clinical trial supply chain. It allows organizations to tap into specialized expertise and reduce operational burdens. By choosing the right partners, Pharma and Biotech companies can offload some of the the complexities of clinical trial supply effectively and focus on bringing new life-saving therapies to market.

CSI 2025: A Year of Growth, Impact, and Innovation

Browse our top comparator medicines with CoA, including leading oncology and biosimilar products, available through qualified global manufacturers and suppliers. Top Product List with CoA Working with CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs Abraxane nab-paclitaxel Avastin bevacizumab Bavencio avelumab Caelyx liposomal doxorubicin Caprelsa vanvdetanib Darzalex daratumumab Dupixent dupilumab Eylea aflibercept Herceptin trastuzmab Humira/Amgevita/Yuflyma adalimumab Ibrance palbociclib Jakavi/Jakafi ruxolitnib Keytruda pembrolizumab Lucentis ranibizumab Mabthera/Truxima rituximab Mounjaro/Zepbound tirzepatide Ocrevus ocrelizumab Ozempic semaglutide Ozempic/Wegovy semaglutide Polivy polatuzumab vedotin Rybelsus semaglutide Stivarga regorafenib Talzenna talazoparib Venclyxto venetoclax Yervoy ipilimumab Zytiga abiraterone acetate Brand Name Scientific Name Frequently Supplied Comparator Medicines Partnering with CSI streamlines your clinical trial supply chain, ensuring the timely and cost-effective sourcing of high-quality comparator drugs. With our scientific expertise, we offer guidance on new investigative medicines while leveraging our global reach and unwavering focus on quality. CSI specializes in supplying oncology products for global clinical trials, having successfully supported over 1000 trials. Our offerings range from generics to advanced cold-chain biologics. We also have extensive experience in providing biosimilar medicines for diverse clinical trials, expertly navigating complex regulatory requirements worldwide. Our strong relationships with over 200 leading manufacturers and a global network of trusted suppliers position CSI as your ideal partner for biosimilar and oncology product needs.

CSI delivers bespoke global clinical trial supply chain solutions, from sourcing medicines and ancillaries to storage, distribution and project management. We provide world-leading, bespoke clinical trial supply chain solutions Clinical Services International (CSI) delivers best-in-class clinical trial supply solutions by developing tailor-made sourcing strategies for our partners, carrying out proactive project management, and ensuring the timely and efficient distribution of medicines and medical devices. When procuring medicines and ancillaries for our partners’ clinical trials, we know that delivering the right sourcing strategy can yield massive savings. Our unparalleled access to products manufactured around the world and our logistical capabilities mean we have never failed to deliver to a study. Our Services Medicines and Ancillaries Storage and Distribution Project Management Medicines and Ancillaries Storage and Distribution Project Management Medicines and Ancillaries Comparator Drug Sourcing At CSI, we take a scientific approach to comparator sourcing based on our 25 years of experience in the clinical trial supply industry. Comparators are on the critical path of almost all clinical studies but are increasingly expensive and hard to find. We pride ourselves on finding the unfindable, sourcing comparator drugs that allow clinical trials to run on time and provide better patient outcomes. The clinical supply partner of choice Pharmaceutical companies , biotechnology companies and Clinical Research Organisations (CROs) must have robust comparator sourcing strategies in place to ensure that comparator drugs are supplied to all clinical trial sites at a competitive price and without disruption. CSI has supplied medicines to over 1,000 clinical trials across lifecycle phases 1 to 4, supporting our partners with even the most complex and challenging requirements. We understand that every clinical study is different and requires a customised approach. With the experience to take on even the most complex adaptive trials, we know how to reduce complexity and drive value, delivering sourcing strategies to improve the speed and agility of your study. CSI delivers results with: A comprehensive understanding of clinical trial requirements and protocols Fully bespoke sourcing solutions, whether country-specific, global or hybrid A global network of qualified suppliers, manufacturers and wholesalers A wide range of suppliers to minimise risks and enable sourcing of specific batches Full documentation, client support and supply chain transparency CSI’s six drivers of effective comparator sourcing Understanding the science behind a clinical trial informs CSI’s efficient supply strategies Protocol interpretation Protocol interpretation Product access Product access Supply continuity Supply continuity Cost control Cost control Speed Speed Supporting documents Supporting documents graph Our most frequently supplied comparator medicines Abraxane nab-paclitaxel Oncology Avastin bevacizumab Oncology Bavencio avelumab Oncology Brand Name Sciticifc Indication Eylea aflibercept Ophthalmology Humira adalimumab Arthritis Ibrance palbociclib Oncology Jakavi ruxolitinib Oncology Keytruda pembrolizumab Oncology Lucentis ranibizumab Ophthalmology Mabthera rituximab Oncology Opdivo nivolumab Oncology Roactemra tocilizumab Arthritis Stivarga regorafenib Oncology Talzenna talazoparib Oncology Tecentriq atezolizumab Oncology Yervoy ipilimumab Oncology Branded Name Scientific Name Indication Overcoming the challenges of comparator drug sourcing The sourcing of comparator drugs and non-investigational medicinal products (NMPs) has become increasingly critical as most drugs are now tested against the standard of existing care. Despite market growth and development, it is becoming more difficult to guarantee the timely availability of comparator drugs due to many of the products being biologic medicines , which are difficult to produce and distribute. Working with CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner. Our scientific expertise means we can advise on new investigative drugs and, with our global reach and emphasis on quality , you can always rely on us to deliver. Case Studies Oncology Products Biosimilars Oncology Products CSI specialises in supplying oncology products to global clinical trials. We have successfully delivered oncology products to more than 1000 studies, from generics to the most sophisticated cold chain biologics Discover more Biosimilars CSI has extensive experience of supplying biosimilar medicines to a wide range of clinical trials, including the navigation of strict government regulations around the world. Our strong relationships with leading manufacturers and our global network of trusted suppliers make us the ideal supply partner for biosimilars. Discover more Comedications The standard of care for many indications, especially in oncology, is now a combination of drugs that together provide maximum efficacy. Comedications may be used to alleviate side effects or to improve the potency of the treatment. Comedications are common in cancer treatment because of the multitude of biological mechanisms at play in disease progression. Combination therapies play a crucial role in the comprehensive care of patients, from managing risks to creating synergies that give the gold-standard of treatment. Critically, for clinical trials, the increasing prevalence of combination therapies being used as comparators means more complexity and greater risk from delays, drug shortages, disruptions and compromised supply chains. Securing multiple products on time, and in the right condition, is even harder when each requires a different supplier and logistics solution. CSI has the expertise and experience to help our partners to overcome these challenges. Our scientifically-minded team has the knowledge to advise on the optimal sourcing strategy for all comedications and combination therapies that might be required for any trial, factoring in origin of supply, price, logistics and shipment timing. Rescue Studies We apply our same expertise, global footprint and operational excellence in service of global studies that may need rescuing, whether this relates to issues of procurement, sourcing, resource, compliance, quality or timelines. With CSI’s decades of experience in the clinical trial supply industry and dedicated client relationship managers, we are here to help you get your study back on track. CSI has sourced rescue medications for a range of global studies, including the supply of infliximab, salbutamol, ruxolitinib and mycophenolate motefil. Case Study Direct-to-patient services for decentralized trials Streamline your supply chain by combining Direct-to-Patient and traditional clinical trial services Direct-to-Patient (DTP) services enable decentralized clinical trials by delivering investigational products directly to patients’ homes. CSI offers four flexible DTP models. Clinical Site-to-Patient, Depot-to-Patient, Pharmacy-to-Patient, and Hybrid to ensure temperature control, compliance, and patient convenience. These models help accelerate timelines, improve trial quality, and support enrollment in studies involving rare diseases or dispersed patient populations. Sending IMPs from a site depot/CP to a home nurse, who then delivers to patients at the time of their home visit ----- H2---- Hybrid Option Central pharmacy to patient is best suited for temperature control / minimize deviations ----- H2---- Pharmacy to Patient GMP depot to patient – Best suited for temperature control / minimize deviations ----- H2---- Depot-to-Patient The IMP is shipped directly from the main or sub depot to the patient home. Nurse services may be added ----- H2---- Clinical Site-to-Patient Considerations about DTP Key benefits and challenges of adopting Direct-to-Patient models Ideal for trials involving a rare disease, orphan indication, or dispersed patient population Decrease timelines Improve quality Reduce costs Enroll and retain more patients Process complexity Ensuring GMP compliance CSI therapeutic areas Oncology Cardiovascular Respiratory Neurology Infectious Diseases Immunology Autoimmune Endocrinology Metabolic Disorders Hematology Gastroenterology Dermatology Ophthalmology Nephrology Urology Orthopedics Rare Diseases Vaccines Medical Devices and Ancillaries As well as medications, clinical trials often require a wide variety of ancillary supplies, including medical devices, technological equipment, disposable products and print materials. 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. Leveraging our partnerships with leading manufacturers, we can offer significant cost savings on medical devices and ancillaries required to support our partners’ clinical trials, including: 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 Medical equipment Technological equipment Print materials START Electrocardiogram (ECG) tests Spirometers Weighing scales Blood pressure monitors Infusion pumps Cooled or uncooled centrifuges Refrigerators Visit our Sustainability page eDiaries Mobile devices Laptops Printers Pill splitters Investigator site files Pharmacy binders Patient recruitment material Storage and Distribution CSI has delivered comparator medicines, medical devices and ancillaries to thousands of clinical trials around the world. Our extensive experience and global reach mean we can advise our partners on the best strategy for supplying any study – whether this involves direct-to-site shipments, local or regional depots, or hybrid solutions – to ensure the necessary products arrive on time, within budget, and at the required location. We understand the challenges of managing a complex clinical trial supply chain and can deliver to your site, warehouse or packaging agent. CSI’s integrated, end-to-end distribution solutions allow our partners to maintain focus on the drug development process, keeping studies flexible, agile and on schedule. Delivering for our partners Strategically positioned global depot network International clinical trials require global facilities in strategic regions combined with local insight and experience of a variety of regulatory requirements. CSI’s global depot network spans 60 countries and six continents, allowing us to identify the most cost-effective solutions for any trial supply, while maintaining flexibility and allowing for contingencies. - Our Global Reach Warehouses and offices Our network extends to 60 countries on six continents Specialized Cold-Chain Logistics CSI provides end-to-end cold and ultra-cold chain logistics for temperature-sensitive clinical trial supplies. We plan, source, pack, store and deliver medicines globally at 2–8°C , –20°C , and –80°C , using GDP-compliant processes, validated packaging and qualified couriers Our global network of qualified logistics providers ensure full product integrity through real-time temperature monitoring and data logging. All shipments are supported by risk assessments, route mapping and contingency planning to prevent temperature excursions. CSI’s expertise covers high-value and short-shelf-life products, including biologics and oncology therapies. We manage site-specific requirements, customs clearance and product handling across multiple regulatory regions. Our cold-chain solutions are built to support global Phase I–III trials with scalability, reliability and full regulatory compliance. Global expertise with unrivalled global knowledge CSI is headquartered in London and has offices in the United Kingdom, the United States, Germany, and China. Delivering clinical trial supplies to some of the world’s most difficult-to-reach markets, our experienced and knowledgeable teams have comprehensive knowledge of import and export logistics, as well as the movement of investigational medicinal products (IMPs) across all global markets. Our international reach ensures we can source the clinical supplies needed for even the most complex trials and deliver them on time and within budget. Locations We overcome distribution challenges CSI’s flexible clinical trial supply strategies ensure we can overcome any distribution challenges that might affect the outcome of our partners’ clinical trials, including: Breakdowns in the logistical supply chain Slow-paced patient recruitment Resource availability Fluctuation in demand Expiring batches Our clinical distribution strategy covers logistical planning, imports, exports and inventory shelf-life control, and our centralised compliance team oversees the entire study. This reduces vendor complexity and ensures clinical supplies are delivered within the agreed timeframe. Project Management We value clear communication Throughout the clinical trial supply process, CSI implements study-specific systems to update and communicate clearly and regularly with our partners and supply network, so all parties are kept informed of the status of clinical trial supplies. To aid transparency and efficiency, each of our partners is assigned a dedicated project manager from CSI who is responsible for overseeing the project from the proposal stage to delivery. Direct-to-site delivery For open label studies, CSI can deliver directly to sites in a fast, reliable and cost-effective manner. We work closely with project managers, assisting with trial forecasts to ensure that medication is available at all sites when needed. Our flexible and adaptive solutions help our partners to save resources and facilitate effective patient recruitment and retention. Controlled transport and storage CSI is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Berlin State Office for Health and Social Affairs (LAGeSo). We are experts in cold chain biologic, temperature-controlled and ambient product delivery, and our quality management system ensures full compliance with regulatory requirements around the world. All our depots are audited to ensure the highest standards of Good Manufacturing Practice (GMP), while our end-to-end transport and storage services are monitored at every stage of the distribution process. Quality Secure shipment tracking All CSI warehouse and shipment activities are tracked using GPS and our specialised inventory system, so we are always in control of our stock levels and can guarantee full traceability from pick-up until delivery. We provide partners with full visibility throughout the logistical process, and our tracking system efficiently flags low stock levels and impending expiry dates. We can also provide, as required, customised inventory reports that document: Materials Tracking numbers Shipment and receipt date Serial numbers Batch numbers Temperature records Materials Tracking numbers Shipment and receipt date Serial numbers Batch numbers Temperature records Returns, reconciliation and destruction CSI also handles returns and destruction at the site level. We can return damaged, expired or unused medications to our warehouses for final reconciliation destruction. We produce comprehensive final reports as part of the close-out document of the study. Contact Us Project Management CSI has over 150 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. We have never failed to deliver to a study 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 150 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 CSI carries out comprehensive scenario planning from the protocol analysis stage onwards. Once a clinical trial is underway, we regularly review forecasted supply requirements against actual drug use to minimise wastage and unnecessary costs. We can also pool inventories for study programmes to reduce waste and to save money for our partners. CSI reduces complexity and adds value by: Sending IMPs from a site depot/CP to a home nurse, who then delivers to patients at the time of their home visit ----- H2---- Hybrid Option Central pharmacy to patient is best suited for temperature control / minimize deviations ----- H2---- Pharmacy to Patient GMP depot to patient – Best suited for temperature control / minimize deviations ----- H2---- Depot-to-Patient The IMP is shipped directly from the main or sub depot to the patient home. Nurse services may be added ----- H2---- Clinical Site-to-Patient 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 Contact us Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements Company type Submit