Learn more about local comparator sourcing and the advantages it can bring to clinical trials Comparators are increasingly being used in clinical trials to test the efficacy of investigational medicinal products compared to the existing market product. As the number of clinical trials across the globe grows, the demand for reference drugs, or comparators, is mounting. This demand puts pressure on comparator sourcing partners to source enough comparator products within the required timeframe and budget for the clinical trial design. Comparator sourcing partners use knowledge of global markets to choose the most appropriate sourcing strategy, whether it is local, central, market or manufacturing sourcing. Local comparator sourcing is a strategy many sourcing partners use, due to the availability, efficiency, and affordability of supply. What is local comparator sourcing? Local comparator sourcing is a sourcing strategy whereby the comparator product is bought within a single country and used in a clinical trial within the same country. The product avoids import and export charges and regulations, which can speed up the clinical trial supply chain and save costs. When implementing a local sourcing strategy, comparator sourcing partners liaise directly with manufacturers in the trial country, to source products at the right quantity and within a suitable expiry for the length of the study. Depending on the supplier’s relationship with the manufacturer, the product can be shipped directly to the trial site, depot, or patient, compared to sourcing from the open market and struggling with availability of supply. What are the benefits of local comparator sourcing? 1. Delivery within the required timeframes A significant challenge when sourcing comparators from global markets is delivering drugs on time so they can be used in the clinical trial within the product expiration date. Typically, local comparator sourcing enables sourcing partners to obtain products quicker than they would via other sourcing strategies. Complications caused by Brexit can cause further delays when importing and exporting comparators into other countries within the required timeframe. As the product is sourced and used within the same country or region, comparator products are available much sooner. This is because the products do not have to be exported and imported into a different country, pass through customs, and meet regulatory requirements, and reach the depot site before being ready for use within the trial itself. 2. Language of documentation Documentation, such as certificates of analysis, is crucial to show the chain of custody from the source to the destination. Translating documents into another language may result in important regulatory requirements being misinterpreted. Sourcing and supplying comparators in the local language to clinical trial sites and trial participants is incredibly advantageous. Language barriers cause significant delays to the clinical supply chain and require translators to produce all documentation and labels in the local language of the trial and its participants. When the documentation is already in the local language, all stakeholders can readily read the documentation and product labels to understand how the product is to be used. 3. Significant cost savings Reducing delays within the clinical trial supply chain caused by product shortages, availability of supply, import and export, shipment and delivery, regulatory requirements can help make significant cost savings. Sourcing partners can leverage relationships with local manufacturers and suppliers to understand timelines and market knowledge, and overcome demand and product shortages, to obtain products cheaper than on the open market. In addition, bypassing import and export requirements can reduce the amount of paperwork and documentation required, which can lead to potential tax savings. This is furthered by reducing the number of distribution networks required to transport the product from country to country, again leading to tax savings. CSI (Clinical Services International) is a world leading comparator sourcing partner Local comparator sourcing provides many advantages and opportunities for reduced timelines, efficient supply, and cost savings. It must be noted that whilst it is a highly effective strategy, it is not a one size fits all solution. Comparator sourcing partners, like Clinical Services International, will take the most appropriate route to improve the speed and agility of your clinical trial. We leverage our global network of over 95 manufacturers to source high-quality comparator drugs and ensure the efficient, effective delivery of your studies. We improve trial success rates by securely sourcing comparator drugs in short supply with the longest expiry, ensuring comparators are available for trial participants at the right place and time. Contact us to discuss how we source comparators to ensure the successful supply of your clinical trials.

Read our tips to help you reduce the risk associated with comparator sourcing Like all supply chains, comparator sourcing poses substantial risks, such as sourcing comparator drugs, obtaining the correct documentation, supply chain delays and compliance with local and global regulations. With our science-based approach and over 25 years of experience in comparator sourcing, we have a detailed understanding of the risks it brings. Here are three ways you can reduce the risks to ensure your comparator sourcing strategy is a success, whilst keeping your clinical trial on schedule. Build a global network Clinical trials can span across countries and continents, meaning comparator drugs will travel thousands of miles. Throughout the logistical process, the comparators need to be labelled, packaged and sent through customs for each country. All this can quickly lead to delays and incorrect quantities of the products being delivered if you don’t have a trusted network across the world. Our reliable global network developed over 25 years means that the comparators we send to clinical trials can ultimately arrive at the correct destination and on time so the study can remain on schedule. If any challenges arise, our close relationship with our global suppliers help us solve them. Leverage good supplier relationships Having a global network is one thing, but it’s important to leverage this network and establish good relationships with suppliers. Suppliers must have a good reputation and come with years of experience in clinical trial supply chains. The focal benefit of having good supplier relationships is it increases the likelihood of overcoming supply chain issues and delivering the comparators on time and on-budget - but there are other factors to consider too. Significant risks to comparator sourcing comes in the form of regulatory adherence. Failing to adhere to the regulations will soon result in lengthy delivery delays and can equally result in the products not being delivered at all – putting the clinical trial at risk. Each country will have varying levels of import and export regulations - and with it, different numbers of documents to fill. Working with suppliers who have an in-depth knowledge of the regulations will help ensure that you remain compliant, resulting in the comparators being delivered on schedule. At CSI, we have built outstanding relationships with our suppliers, which means that we have never failed to deliver medicines for a clinical trial. Forecast risks Issues with the supply chain, such as stock issues and product delays can greatly hamper clinical trials. However, forecasting and planning for these issues can help overcome them and keep the clinical trial on schedule. Direct to site distribution can help deliver comparator drugs quickly and reliably to clinical trials, saving you time and money. However, the main factor to consider is to analyse every possible opportunity for challenges emerging. We analyse every stage of the clinical trial supply chain by implementing a 6-step risk manage process: Identify Evaluate Control Communicate Review Report The result of this process is that our comparator sourcing strategies are always fit for purpose and works to minimise risks with the clinical trial supply chain. Choose the right comparator sourcing partner Overcoming the risks with comparator sourcing is a complex process. So, having the right partner is essential. Working with CSI can optimise your comparator sourcing strategy and ensure high quality comparators are sourced on budget and on time. While our headquarters are in London, we operate in the UK, Germany, Japan and the USA. Using our science-based approach, we leverage our global network and country-specific expertise to source comparator drugs from audited suppliers, originators and dedicated wholesalers in Europe, the USA, Latin America and the Asia Pacific (APAC) while maintaining regulatory compliance. Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.

Thinking of adding emerging markets to your global comparator network? Learn more about the implications of this in our most recent blog As clinical trials span countless countries, global comparator sourcing from emerging markets, such as Asia, has become increasingly appealing. However, this approach brings with it numerous risks (as well as benefits) for clinical trial supply companies. Partnering with a business such as CSI, which has an established global network of suppliers, will go a long way to minimising these risks. Here, we delve into the considerations when looking to take comparator sourcing to emerging markets. Cost Partly why global comparator strategies look to source from emerging markets is due to the cost of the drugs. In most cases, they are cheaper than ones in more established regions, such as Europe. While the initial cost of the drugs can be cheaper, the cost of transportation can be higher, depending on the destination. Taking the clinical trial close to where the drugs are being transported from will mitigate some of those costs – but if not, you will need to calculate the total cost compared to buying in regions closer to the delivery site. By partnering with CSI for your clinical trial, we can calculate the costs associated with global sourcing from both emerging and established markets, allowing you to take the correct approach. Time As emerging markets are often on the other side of the world from Europe and North America, delivery times can be longer. You will need to account for this in your global comparator strategy. We recognise that delivery times are paramount to a clinical trial, which is why our global network has never failed to deliver drugs for a clinical trial on time. Sourcing Increasing demand for comparators caused in part by COVID-19 has led to a shortage of supply. Therefore, alternatives must be developed to reduce the risk it can have on your comparator sourcing strategy. A viable alternative is looking to source drugs from emerging markets. Of course, there is no guarantee that the correct ones are available in these alternative locations, but it is an option that needs to be considered. Our global network at CSI includes emerging markets partly for this reason. Drug safety Clinical trials used to be considered a risky endeavour in emerging markets due to the possibility of lower quality and/or counterfeit drugs. In recent years, however, there has been more transparency from governments within these emerging markets. They recognise the missed opportunity of not having suitable drugs for clinical trials, so they have enacted regulations to combat this. With over 25 years of experience supplying clinical trials, we ensure that every drug we supply is of excellent quality, regardless of where they are sourced from. Regulations Understanding the regulatory requirements are paramount when sourcing from emerging markets. You should know in detail the required paperwork needed to import and export from these markets so you can avoid delays at customs. Nevertheless, you should still factor customs inspections and temperature excursions into your comparator sourcing strategy. Countries in emerging markets will also have different customs duties and taxes, such as VAT, which will need to be factored into your budget. At CSI, we have an established global network, meaning we expert knowledge of global sourcing, whether that is from established or emerging markets. While our headquarters are in London, we operate in the UK, Germany, Japan and the USA. We leverage our global network and country-specific expertise to source comparator drugs from audited suppliers, originators and dedicated wholesalers in Europe, the USA, Latin America and the Asia Pacific (APAC) while maintaining regulatory compliance. Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.

Patient-centric approaches to clinical trials have dramatically increased in recent years. How does comparator sourcing fit into this new landscape? Patient-centric approaches to clinical trials have been around for years, but ever since the pandemic - whereby the number of patients being at home dramatically increased – patient-centric approaches have increased. Here, we discuss how it can adapt to comparator sourcing. As the name suggests, a patient-centric approach is when the clinical trial is centred around the patient. The focal purpose of this approach is to reduce the burden on patients with better outcomes. However, for pharmaceutical companies running trials, it is also a way to meet their recruitment targets, which are often missed using a traditional method, and to recruit more quickly. How it works with a comparator sourcing strategy Neither a patient-centred clinical trial nor any other clinical trial can be conducted without the correct drugs delivered to sites at the right time. As comparator drugs shortages become more prominent, a viable patient-centric approach can be difficult to implement. The very nature of a patient-centric approach means that some patients may need to have drugs delivered to their homes as well as to the trial sites. After all, the patients may have work or family commitments. So, an agile comparator sourcing strategy is needed in this regard to deliver drugs to home addresses as well as to depot sites. With the recruitment of patients being shortened with patient-centric approaches compared to more traditional trials, there is also the potential for more trials to take place, which leads to further demand for clinical supplies. As a result, a reliable clinical trial supply company that can meet this demand is needed. At CSI, we deploy our global network spanning 25 countries and 6 continents - meaning we can source comparator drugs, even for the extra demand required with patient-centric clinical trials. Read on to discover the comparator sourcing factors that help develop a successful patient-centric approach. Direct-to-site distribution One of the key factors to a successful comparator sourcing strategy for patient-centric clinical trials is direct-to-site distribution. This works well with patient-centric approach as there is the need to deliver the supplies directly to the patient. In CSI's direct-to-site distribution services, supplies are delivered to the trial by fewer vendors, so they arrive to patients faster. We also ensure that all the supplies remain temperature controlled and are of the correct quality, even with the more difficult delivery conditions of patient-centric trials. Global network Another factor in having a successful comparator sourcing strategy with patient-centric clinical trials is a global network. The network needs to be extremely well connected to allow for fast delivery times to localised storage facilities. Through our global network, we can deliver comparator drugs to sites worldwide rapidly and meet the needs of patient-centric trials. Choosing the right comparator sourcing partner To minimise the complex logistics of clinical trials, choosing the right comparator sourcing partner is essential. This is because they can source the right drugs at the right time with a flexible distribution strategy that can meet the varied needs of the trials. They can overcome the challenges involved with delivering to clinical trials, so you can focus on running your study seamlessly. As a global leader in comparator sourcing, we can give you visibility of the clinical trial supply chain. More importantly, however, we can ensure that your comparator drugs are delivered within the agreed timeframe – no matter the end location. We can help with your patient-centric clinical trial Working with CSI can optimise your comparator sourcing strategy and ensure high-quality comparators are sourced on budget and on time to your patient-centric clinical trial. While our headquarters are in London, we operate in the UK, Germany, Japan and the USA. Using our scientific expertise, we leverage our global network to source comparator drugs from audited suppliers, originators and dedicated wholesalers in Europe, the USA, Latin America and Asia Pacific (APAC) while maintaining regulatory compliance. For more information on our comparator sourcing services, contact us today.

Read our featured article in Arena International’s latest clinical trial supply handbook, which discusses risk management of clinical trial supplies Our article entitled ‘Risk Management of Clinical Trial Supplies’ discusses strategies to mitigate drug shortages when sourcing comparator or co-medication for your clinical trial. In Arena International’s latest CTS publication, we demonstrate our scientific expertise in drug management and developing robust clinical trial supply strategies. The CTS handbook is the go-to guide for professionals in the global clinical supplies space. It’s a knowledge base for the clinical supplies community, with insights from leading industry experts, including CSI. Read our feature here What we highlight Risk mitigation Comparator and co-medication drug shortages Clinical supply chain challenges How CSI addresses them with our scientific expertise, experience and relationship with manufacturers As our feature explains, there are numerous risks involved when sourcing drugs for clinical trials – making partnering with a reliable sourcing partner invaluable. Using our science-based approach, we can support you in identifying the risks and backup options to be prepared for drug shortages and developing a flexible sourcing strategy. We leverage our global network of over 95 manufacturers to source high-quality comparator drugs and ensure the efficient, effective delivery of your clinical trial. So, if you enjoyed reading our article and wish to discuss your clinical trial requirements with Clinical Services International, contact us today.

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/