We discuss the importance of comparator medicines in Arena International's 2023 Outsourcing in Clinical Trials handbook Our article entitled ‘Budgeting for Clinical Trials: The Importance of Comparator Medicines’ appears in the 2023 Outsourcing in Clinical Trials (OCT) handbook by Arena International. Due to the growing number of global trials, and their increasing complexity, as well as drug shortages becoming more prevalent, sourcing comparator drugs has become more difficult. With over 25 years of experience supplying clinical trials, we have gained a deep understanding of the availability of comparator drugs across the globe and what considerations organisations should take when creating their clinical trial budget. The OCT handbook is the go-to guide for professionals in the global clinical outsourcing space, with insights from leading industry experts, including Clinical Services International (CSI). Read our feature here What we highlight General considerations when preparing a clinical trial budget Ethical considerations and competition among clinical trials driving comparator demand Factors to consider when building your comparator sourcing budget Risk mitigation in comparator sourcing As the article explains, budgeting for comparator drugs isn’t a simple process, with numerous potential pitfalls. As a result, having a comparator drugs supplier who can overcome these challenges is essential. With our network of over 95 manufacturers across more than 50 countries and six continents, CSI can optimise your comparator sourcing strategy and ensure that high-quality, on-time, and on-budget comparator drugs are delivered to your clinical trial. If you enjoyed reading our article and want to discuss your clinical trial requirements with CSI, please  contact us  today.

Read all about our commitment to sustainable procurement Sustainability has become a top priority for companies across various industries, with an increasing number of businesses acknowledging the need to minimise their environmental impact and adhere to ethical principles. At Clinical Services International (CSI) we have taken this commitment seriously and have recently become EcoVadis certified, a globally recognised benchmark for sustainability in the supply chain. Why Has CSI Become EcoVadis Certified? CSI recognises the importance of sustainable procurement, which is an ethical movement rapidly gaining momentum. Studies show that the vast majority of procurement leads prioritise sustainability as critical or very important. Sustainable procurement is driven by cost savings and risk mitigation, which yield further benefits such as increased sales, differentiation of offers, and enhanced innovation in the supply base. By being recognised as an EcoVadis accredited business, CSI hopes to set itself apart from competitors and appeal to clients who are seeking medicines for their trials from more sustainable suppliers. What is CSI’s Sustainability Vision? CSI’s sustainability vision is centred on seeking growth that is in harmony with the environment by minimising the impact of its business operations on the environment and people around it. The company has taken various steps to achieve this goal, such as reducing the use of paper, encouraging virtual meetings, and promoting cycling to work or using public transport. CSI aims to increase efficiency and reduce the environmental impact from its company operations, including lowering costs through reductions in energy consumption and waste. What is the Benefit to CSI and its Clients? By adhering to sustainable procurement practices and achieving EcoVadis certification, CSI is demonstrating its commitment to corporate responsibility and setting itself apart as a transparent and adaptive company. This can lead to operational cost savings, increased customer loyalty, and a stronger brand reputation, which can attract new clients and partnerships. How Does Sustainability Affect Day-to-Day Supply Chain Decisions? Applying sustainability principles to procurement can be challenging due to conflicting GDP regulations, such as the need for single-vehicle shipments or the transit of a single pack of medicine. Furthermore, wastage arising from medicine impairments, rejections, recalls and short expiry dates cannot be avoided due to the need to ensure patient safety within the medical industry. However, CSI can support sustainable procurement practices by favouring EcoVadis rated companies that adhere to specific social and environmental standards. CSI ensures that all its suppliers are audited and qualified against important criteria, such as environmental compliance. CSI’s commitment to sustainable procurement is a step in the right direction, not just for the company, but also for the industry and planet. The EcoVadis certification is a testament to our dedication to environmental responsibility and ethical business practices. EcoVadis, Labour and Human Rights EcoVadis certification not only represents a company’s commitment to sustainability, but also to responsible and ethical practices within the workplace. CSI embraces all EcoVadis virtues and is proud to offer its employees optimum working conditions, payment terms, opportunities for continued educational and personal development, and wellbeing services.

Learn about CSI’s expert risk management strategies One of the biggest challenges faced by clinical trial supply management companies are drug shortages in the supply chain. The FDA Drug Shortages list currently includes carboplatin, paclitaxel and fludarabine oncology medications, and there has been a notable increase in the number and frequency of such shortages. When it comes to drug shortages, there are several contributing factors, including disruptions to manufacturing and supply, regulatory issues, fluctuations in market demand, and pricing and reimbursement policies: Manufacturing and supply issues are the main cause of drug shortages and can be the result of a scarcity of raw materials, or logistical and business errors. Regulatory and quality control issues arise when agencies impose restrictions or require additional safety measures to ensure the quality of the medications, which can delay their production and distribution. Seasonal demand and increased demand, especially during epidemics or pandemics, can lead to medicine shortages in specific regions. Pricing and reimbursement policies are another major reason for medicine shortages: when the price of a medication is too low, manufacturers may choose to stop producing or reduce the amount they produce, which can lead to shortages in the market. The effects of these shortages can result in life-saving medications becoming unavailable to patients, risking their treatment and the outcomes of a clinical trial. In a worst-case scenario, drug shortages can lead to increased study timelines and costs. Clinical Services International (CSI)’s solution? To deliver proactive strategies and interventions that counteract the risk of drug shortages. CSI has the expertise We leverage longstanding relationships with manufacturers who have global coverage to enable better access to medications with low availability. Communication with the drug manufacturer ensures early identification and resolution of any potential supply chain issues. CSI has qualified over 95 leading manufacturers globally, maximising our access to even the most hard-to-find medicines. Early-stage planning With our logistical expertise and in-depth knowledge of drug development cycles, we ensure there is enough time to source the required medication for the duration of a clinical trial. CSI will propose a reliable sourcing model to provide sufficient quantities of the drug at the right time. Diversifying sources of medication Diversifying the sources of medicine procurement can reduce risk by avoiding the need to rely solely on one source of supply. CSI identifies the best sourcing strategy and alternative drug sources in case the primary supplier experiences any issues. These can be local or global, and a backup plan will always be in place to ensure a consistent supply of medication. By following these guidelines, CSI minimises the risk of medicine shortages and helps to ensure the smooth running and success of clinical trials around the world. Read our case study demonstrating how CSI has overcome drug shortages by leveraging relationships with multiple manufacturers. Contact us to find out how CSI’s team of experts can with assist your oncology trials.

Diabetes Week (12–18 June 2023), set up by the British charity group Diabetes UK, provides a special opportunity and focal point to improve education around diabetes and to raise awareness of this chronic condition Diabetes affects the levels of insulin in a person’s blood. There are two forms of diabetes; type 1 and type 2. Type 1 diabetes results from the body’s failure to produce insulin, which leads to a high level of glucose in the bloodstream. It is treated by injecting insulin into the body daily to keep blood glucose levels under control. In type 2 diabetes, a person's body cannot make enough insulin or make the insulin that it produces work properly. This type can be treated with medicated insulin, and it can also be managed through a healthy diet and exercise. How is diabetes treated? The medicine diabetes patients take depends on the type of diabetes they have and how well the medicine controls their blood glucose levels. Different diabetes treatments work in different ways to lower blood sugar and often a combination of medicines is required to treat the condition effectively. Type 1 diabetes must use insulin as the body cannot produce it. It is the most common type of diabetes in children. Type 2 diabetes does not always require insulin, it can be managed with a healthy lifestyle, oral medication or some may need insulin depending on the patient. Medication can change over time depending on how your body reacts at different stages of the chronic condition. Young people with diabetes will experience a change in medication or lifestyle as they transition into adult care. A management plan can help young people understand their diabetes care. The plan should outline how to manage blood glucose levels, encourage healthy eating habits, encourage physical movement, prepare for emergencies and seek mental health support. A diabetes management plan can support young people to take actionable steps towards their condition care. Insulin treatment There are different types of insulin available to treat diabetes. Each type works at different speeds and the effects last a different length of time. They can be administered in many ways depending on the patient’s preference. The type of insulin prescribed by doctors depends on the type of diabetes, how the body reacts to the treatment, other health conditions and the patient’s financial position. Young people will need support from parents or carers when administering insulin if they find it uncomfortable or are too young to handle the needles themselves. As they get older, they will eventually be able to do this without any help. Types of insulin: Rapid-acting: Works 15 minutes after injection, peaks at 1 hour, lasts 2 to 4 hours Short-acting: Works 30 minutes after injection, peaks at 2 to 3 hours, lasts 3 to 6 hours Intermediate-acting: Works 2 to 4 hours after injection, peaks at 4 to 12 hours, lasts 12 to 18 hours Long-acting: Works several hours after injection, does not peak, lasts for 24 hours Types of insulin administration: Needle and syringe: Draw the dose of insulin from the vial into the syringe and inject it into the belly, thigh, buttocks or upper arm once or two to four times a day. Pen: Some come filled with insulin and are disposable and others require patients to insert an insulin cartridge and replace after use. Pens cost more than needles but are easier to use. Pump: Provides a small, steady dose of insulin throughout the day. Insulin pumps from the pack worn outside the body through the tube and into the needle inserted under the skin. The needle lasts for several days and pumps insulin into the body 24 hours a day. Importance of diabetes clinical trial participation Diabetes clinical trials are essential to understand more about the disease and how it affects those diagnosed and pre-diagnosed. Before diabetes treatments can reach patients, they must be carefully tested in clinical trials. People with diabetes are crucial to the success of clinical trials. Clinical trial participation ensures scientists and researchers can understand the timelines of recognising symptoms and diagnosing diabetes. Coming together, communities can bring attention to diabetes to learn how to best manage, treat and slow down this disease. Diabetes patients can get involved in clinical trials to test medication and learn which treatments are or are not the most effective for the type of diabetes they have. Researchers can learn which medicine has the fewest side effects and which are the most helpful for long-term diabetes treatment. For example, The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study is looking into the lives of over 5,000 people in the United States with type 2 diabetes to find out which combination of two medications is best for blood sugar management. Clinical trials can look into the genetics behind diabetes and the risks associated with relatives of people with type 1 diabetes. This is referred to as prediabetes. For example, TrialNet is conducting research that includes risk screening for relatives of those diagnosed with type 1 diabetes and how to slow down the disease. Clinical trials also study other aspects of care such as improving the quality of life for people with chronic illnesses. At CSI we have worked on many diabetes studies and have assisted successfully delivering thousands of pens all over the world. We have well-established relationships with all leading manufacturers and as such we can provide cost-efficient and timely solutions and design a robust supply chain to advance your trial.

Quality control measures in clinical trials are essential to ensure the reliability, safety, and efficacy of the investigational medicinal product (IMP). Comparator medications are reference drugs used for comparison against the investigational drug, and their quality is crucial for valid study results. Here are some key quality control measures to be taken into consideration when sourcing clinical trial comparator medicines: Qualified Suppliers: Ensure that the comparator drugs are sourced from qualified and reputable suppliers. These suppliers should have a proven track record of providing high-quality pharmaceutical products. Regular auditing is crucial to verify their adherence to quality standards. Handling and Storage: Implement procedures in line with Good Distribution Practices (GDP) for the handling, transportation and storage of the comparator drugs to maintain their quality and integrity. This includes temperature monitoring and control throughout transit and storage. Documentation: Certificates of Analysis (CoA) can be obtained for each batch of the comparator drug which contains all information about the composition, purity, and quality of the drug and certifies that a regulated product meets its product specification. Batch Release Certificates verify that the comparator drugs are consistent in quality and composition across different batches; variability between batches could introduce confounding factors in the clinical trial results. Regulatory Compliance: Ensure that the sourced comparator drugs meet all relevant regulatory requirements in the countries where the clinical trial is being conducted. This includes compliance with the International Conference on Harmonisation (ICH) guidelines and local regulatory agencies. Quality Oversight: Designate a Quality Control team and Qualified Person to conduct regular inspections and audits to ensure compliance with quality standards. Qualified Persons are responsible for certifying the release of investigational products for use in clinical trials and provide an additional layer of oversight to ensure quality and compliance. Risk Management: Identify potential risks associated with the comparator sourcing process and develop strategies to mitigate these risks effectively. Traceability: Maintain a complete and auditable trail of the sourcing process, from supplier selection to drug delivery. This ensures traceability and accountability in case any issues arise during the trial. Training: Ensure that all personnel involved in the comparator sourcing process are appropriately trained and educated about the importance of quality control and compliance with relevant procedures. Labelling: Proper labelling should be in place to ensure the correct identification and use of the comparator drugs to maintain the integrity of the trial. Handling of Product Returns and Destruction: Ensure there are procedures in place for handling returned or unused investigational products and for the proper destruction of expired or unusable products. How does CSI maintain quality assurance? You should engage with a partner that understands the complexities of regulatory processes and timelines. We pride ourselves on our robust quality assurance processes that ensure the quality of every product and trial we help to deliver. 1. Dedicated Quality Department We have a dedicated quality department whose primary mission is to ensure that you receive the highest quality supplies so your study can run as smoothly and successfully as possible. To ensure your clinical trial supplies are thoroughly quality checked and assured, we provide: • Certificates of Analysis (CofAs) • Batch Release Certificates (BRCs) • Statements of Authenticity (SofAs) • Global market knowledge • Ethically sourced products 2. Qualification processes for suppliers and vendors We visit 90% of our suppliers, especially those based outside Europe. We manage the risks of outsourcing clinical trial supply partners by ensuring stringent processes that prevent issues including supply and delivery. We establish quality agreements with suppliers that define responsibilities, quality expectations, and procedures for deviations and issue resolution. These agreements help create a clear understanding of quality-related roles and responsibilities between the sponsor and the supplier. 3. Global network Through our extensive global network of audited suppliers and manufacturers, we maintain strict compliance with regulations worldwide. Our carefully chosen partners possess in-depth knowledge of local and regional markets, as well as regulatory expertise, often being affiliated with regulatory bodies themselves. These strong partnerships enable us to navigate the necessary processes effectively and adhere to them with precision. 4. Qualified Person (QP) services Our QP is a qualified pharmacist with 40 years of experience in compliance and quality control. We offer many services in supply chain auditing including: · Auditing to GMP/GLP/PICS · Production of QP 3rd party declarations · Batch certification of investigational medicinal products (IMPs) · QP GMP certification of IMP or commercial packaging undertaken · IMPD support (simplified, full compliance review) · Regulatory advice and support · Consultation with a QP · CSI has QPs both in the UK and in Europe Read more on the importance of quality assurance in clinical trial supply Find out 6 ways to maintain compliance in the clinical trial supply chain

The United States is facing an unprecedented shortage of cancer drugs, creating a crisis for thousands of patients nationwide who are experiencing delays or cancellations of their crucial chemotherapy appointments. The impact of these shortages goes beyond current patients, as experts warn that cancer research could suffer significant setbacks for years to come. The shortages are affecting various ongoing clinical trials and may potentially impact over 174 out of 608 trials conducted by the National Cancer Institute alone. However, this figure does not account for the trials that researchers would like to initiate but are unable to due to scarcity. The reasons for these drug shortages are complex, with many cancer drugs experiencing fluctuations in supply over the years. Nevertheless, at least 25 cancer drugs are currently facing critical shortages, including carboplatin and cisplatin, which are particularly vital for research due to their broad application across different types of cancers. Cisplatin and other platinum-based drugs are prescribed to approximately 10% to 20% of all cancer patients, as reported by the National Cancer Institute. The consequences of such shortages are far-reaching and hinder the development of new and potentially life-saving cancer medications. While efforts are being made to address the issue, experts anticipate that cancer drug shortages will persist, denying much-needed help to patients who could benefit from participating in these trials. The situation is adding immense stress to cancer patients and healthcare providers alike, impeding advancements in cancer research and treatment. Clinical Services International (CSI)’s solution? To deliver proactive strategies and interventions that counteract the risk of drug shortages. CSI has the expertise We leverage longstanding relationships with manufacturers who have global coverage to enable better access to medications with low availability. Communication with the drug manufacturer ensures early identification and resolution of any potential supply chain issues. CSI has qualified over 95 leading manufacturers globally, maximising our access to even the most hard-to-find medicines. Early-stage planning With our logistical expertise and in-depth knowledge of drug development cycles, we ensure there is enough time to source the required medication for the duration of a clinical trial. CSI will propose a reliable sourcing model to provide sufficient quantities of the drug at the right time. Diversifying sources of medication Diversifying the sources of medicine procurement can reduce risk by avoiding the need to rely solely on one source of supply. CSI identifies the best sourcing strategy and alternative drug sources in case the primary supplier experiences any issues. These can be local or global, and a backup plan will always be in place to ensure a consistent supply of medication. By following these guidelines, CSI minimises the risk of medicine shortages and helps to ensure the smooth running and success of clinical trials around the world. Read more about how CSI has overcome drug shortages by leveraging relationships with multiple manufacturers. Contact us to find out how CSI’s team of experts can with assist your oncology trials.

The global pandemic has made its presence felt in the world of clinical trials, not least in Phase 1 oncology trials. Vanessa Dekou, Managing Director at CSI, offers her perspective on how COVID-19 is shaping future protocols and challenging conventional wisdom. Patients in self-isolation or quarantine, relocated hospital staff and reduced trial site access are just some of the complications currently facing sponsors of both ongoing and new clinical trials. The need to adapt and innovate quickly has become the top priority and the EMA1, MHRA2 and FDA3, along with many other regulatory agencies, have released specific COVID-related guidance to steer sponsors through the complexities and deviations from the protocol. The temporary changes that have enabled these trials to continue through the pandemic have revealed areas for improvement and may well establish themselves as the default in protocols in the months and years to come. Patient safety Patient safety remains of paramount importance, and the obvious first consideration is ‘whether a patient’s net clinical benefit (clinical benefit minus toxicity) is sufficient to expose them to the risk of contracting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) while on an investigational medicinal product (IMP)’.4 The vast majority of cancer patients are immunocompromised and many trial sites are located in urban centres where there are typically higher infection rates. The pandemic has turned a routine hospital visit into a potentially life-threatening outing, raising concerns about the ability to truly separate cancer patients from the other trial site areas where COVID-19 is being treated. Increasing digitisation The centrality of patient safety has naturally led to remote monitoring, video calls over in-person consultations, and increased digitisation – the process of converting information from a physical format into a digital one – in clinical trials. The pandemic has forced many companies, including our own, to adopt remote working by default, challenging assumptions about how things must be done and accelerating the adoption of new technologies and ways of working. It is inevitable that wet-ink signatures for trial documents will be replaced by digital alternatives – a much-needed change! There are also discussions around ways that increasing digitisation in the sector can streamline the clinical trial process and deliver higher efficiency. For example, ‘duplicate requests by different sponsors for investigator credentials, site feasibility, and declaration of conflicts may be circumvented using an open online database containing accessible information for all’.5 (If we retain and implement all the recent adaptations, it is possible that we may prefer the ‘new normal’ of clinical trials for both patients and clinical trial sponsors.) Flexible delivery We proposed in our previous blog post that direct to patient trials [link] are likely to be on the rise in the future and, in its most recent COVID-19 guidance, the MHRA recommended the following: ‘If a trial participant cannot attend a trial site, then delivery of IMP to a participant’s home is acceptable and no substantial amendment notification to the MHRA will be required. This applies to supply from the trial site or directly from the sponsor.’2 It’s possible that these guidelines will merely accelerate the adoption of direct-to-patient trials to the point where they become common place. The pandemic has also raised questions about the necessity and frequency of in-person contact, and ‘dosing schedules of cancer drugs have been modified where acceptable, and oral treatments, where available, have been leveraged to limit hospital visits. Administration of treatment in local satellite centers [sic] has also been explored, as well as the feasibility of local or even home-based blood draw services and treatment infusions’. Towards a better future The pandemic has challenged the notion of what is essential to the clinical trials process, from recruitment procedures through to dosage frequencies. While we shouldn’t look to put a positive spin on the long-term health impact of many oncology trials being delayed or put on hold, the best outcome for the sector is to ensure that we learn and improve in response to this crisis. The pandemic has created the impetus to question unchallenged conventions – such as the exclusion of certain patient populations from immune-oncology trials – and reflect critically on best practice. A recent Cancer Research UK blog cites Stephen Nabarro, Head of Clinical Operations and Data Management, as commenting: ‘It is important that we find a positive legacy from this difficult time… And one that will come, or we’re certainly hoping will, is a shift in our trials becoming more patient-centric. So much of what we do has historically been focused around the idea that patients must go into the clinic regularly.’6 It’s hard to predict the future, but we can be sure that it will be a future shaped by the pandemic and hopefully for the better. If we retain and implement all the recent adaptations, it is possible that we may prefer the ‘new normal’ of clinical trials for both patients and clinical trial sponsors. If nothing else, that is an outcome worth aiming for. We are excited to support you in your ongoing or future oncology trials, whether this involves updating or developing a protocol, or finding flexible comparator sourcing solutions. CSI delivers medicines on a global scale consistently and with care, and we want to be your next clinical trial supply partner. 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf 2 https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#providing-investigational-medicinal-product-imp-to-trial-participants 3 https://www.fda.gov/media/136238/download 4 https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(20)30339-9.pdf 5 https://jamanetwork.com/journals/jamaoncology/fullarticle/2769924 6 https://scienceblog.cancerresearchuk.org/2020/06/15/covid-19-keeping-patients-on-cancer-clinical-trials/

How CSI supplied large quantities of ruxolitinib to a biotech’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Challenge CSI was approached by a biotech conducting a full global Phase 3 oncology study spanning 14 countries. We were asked to purchase and supply a significant quantity of ruxolitinib within a tight timeframe: with the contract signed in December 2022, the client aimed to have the first sites supplied by March 2023. The client also required three annual resupplies of the oncology medicine to be factored into the request. Solution Within eight weeks, the entire study setup had been meticulously organised, ensuring the smooth and timely execution of the clinical trial supply chain. CSI’s strong relationships with manufacturers around the world and outstanding access to oncology products allowed for the procurement of a substantial volume of ruxolitinib within a short timeframe. CSI’s global depot network facilitated the efficient delivery of the oncology medication without delay – just in time for the client’s tight deadline. Result CSI’s scientific expertise ensured a seamless and smart study setup, with all aspects of the trial addressed meticulously in the supply planning phase. Despite the challenge of working to a tight deadline and the logistical complexities involved in coordinating product supply across 14 countries, nine depots and 67 individual site shipments, CSI successfully delivered a large quantity of the required oncology medicine in line with the client’s needs and expectations. This, in turn, allowed for Site Initiation Visits (SIVs), which had already been scheduled, to take place as planned, keeping the client’s study on track.

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 Challenge CSI was approached to support a quadrivalent influenza vaccine study running in multiple countries in the Northern Hemisphere. The sponsor wanted to use the same product across all participating countries in the trial. Due to the seasonal nature of this vaccine, there is only one production run per year, which takes place each summer: manufacturers look at predictions from the World Health Organization (WHO) for what the dominant flu strain will be the following winter and produce vaccines accordingly. The vaccine doses are typically booked well in advance by customers – around January – and there is very little oversupply. Solution When our client was ready to run the study, several manufacturers in the United States were already overbooked versus their production and would not have been able to support the requirements of the trial in all regions. CSI was able to leverage its longstanding relationship with a major European manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer, CSI demonstrated the equivalence of the EU and USA products. The trial also ran in some South East Asian countries; in order to bypass tricky import requirements, CSI sourced the product locally in these countries. Result With a flu vaccine trial, getting the sourcing wrong can be very costly. Failure to secure supplies would postpone the trial by a full calendar year since the Southern Hemisphere is a poor option when it comes to running a flu vaccine trial, having fewer countries and a circulation of poorly defined flu strains. CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the entire study. Without this strategy, the trial would have been delayed by one year at great expense to the sponsor.

How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Challenge CSI received an urgent request to supply a large quantity of a generic drug for an ongoing Phase 3 trial. These products were initially overlooked by the client as it was assumed the trial sites would supply them. When this was discovered to be unfeasible, the trial initiation date was already close, so the timescale to deliver the products – and keep the trial on track – was extremely tight. Solution We carried out extensive research to determine what drugs were licensed in the countries participating in the trial, which spanned three continents. All major generic manufacturers were approached to ensure coverage across all regions. Working closely with these manufacturers, CSI executed a literature review and obtained equivalency statements for the products required. Approaching a wide range of manufacturers allowed CSI to present the client with a sourcing option that would cover all countries in the trial. The equivalency statements provided proof of clinical equivalency across products, which allowed the trial to proceed. Result Using the evidence gathered by CSI on equivalency across products and the use of unlicensed medication, the sponsor submitted with the two products to country regulators successfully. Approaching two manufacturers was prudent as one manufacturer could no longer support the required quantity at the time of order due to changes in production. Securing a second manufacturer who was able to support the requested volume meant the study ran to schedule. Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy and provided a safety net in the form of a back-up option. The scientific expertise that CSI has was crucial to allowing the trial to follow a central sourcing model, minimising the risk of shortages in supply by only sourcing from one market.

How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Challenge A client approached CSI with a very specific request: to test samples of an expensive oncology product before purchasing the same batches that had passed the testing stage. This was a challenging assignment as it required visibility of batches currently on the market before purchasing, which is only possible in certain markets where product availability is moderate. Due to the nature of the trial, the client was not willing to disclose trial details and required documentation (Certificate of Analysis and Pedigree documents). Solution Without the possibility of disclosure, we had to source the product from the open market. This was challenging because we had to fulfil four requirements: Batch testing Advance visibility of batches Product from specific batch available Documentation The most effective solution was to work with our audited suppliers to devise a ‘hit list’ of batches that had had a positive result in testing. This required close cooperation with suppliers in those markets where batch visibility and documentation were possible, to keep an up-to-date list of batches on the market at any given time, and whether they had had a positive or negative test. Result At CSI, we pride ourselves on implementing effective sourcing strategies for even the most complex trials. In this case, our high level of market knowledge resulted in the successful delivery of the required product and ensured the client’s trial never ran dry. This type of sourcing strategy is dependent on very close communication between CSI, the client, and our suppliers. As suitable markets usually have limited availability, the product had to be collected over time before being delivered to the client in bulk. Guaranteeing a stable supply chain to the client, and ultimately the patient, was paramount at all times. CSI also leveraged its strong relationships with suppliers to keep stock on hold, with the promise to purchase if the batch testing was successful. This solution is only possible when mutual trust exists between all parties, there is a deep understanding of the specific trial requirements, and you have a united team with the determination to deliver for the benefit of the patient.

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 Challenge CSI was asked to support a client’s clinical trial by supplying grass pollen allergen tests to many different countries. There were two main concerns: 1. No product was licensed in all countries where the trial was running 2. The same product had to be used for all patients to ensure consistency in trial results and the sponsor was concerned about sourcing the considerable quantities required within the timeline necessary to support the trial Solution CSI carried out an extensive review of the available literature, gathering evidence on products that were considered equivalent, having largely the same composition to the original product. The licensing aspect was further clarified as the use of unlicensed products was common in many markets. Due to the request for a large quantity of the same product, the optimal sourcing strategy was identified as a central model direct from a manufacturer, rather than relying on local sourcing from many different countries. CSI decided the most suitable option was to approach two independent manufacturers to protect the supply. Result Using the evidence gathered by CSI on equivalency across products and the use of unlicensed medication, the sponsor submitted with the two products to country regulators successfully. Approaching two manufacturers was prudent as one manufacturer could no longer support the required quantity at the time of order due to changes in production. Securing a second manufacturer who was able to support the requested volume meant the study ran to schedule. Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy and provided a safety net in the form of a back-up option. The scientific expertise that CSI has was crucial to allowing the trial to follow a central sourcing model, minimising the risk of shortages in supply by only sourcing from one market.