There are many drivers that affect the cost of clinical trials including the cost of supplies and equipment, increased regulations, transportation and logistics, patient recruitment and complex procedures Streamlining the supply chain and ironing out risks can help to reduce costs and save resources. As a world-leading comparator sourcing partner, CSI delivers the best solutions to ensure your clinical trial runs smoothly, within the most stringent budgets and timelines. Our supply chain management expertise ensures the successful delivery of your clinical trial. Here are 5 ways CSI achieves a cost-effective clinical trial supply chain: 1. Early incorporation of trial supply management Incorporating supply chain management in the protocol design stage ensures that your clinical trial is efficient and cost-effective. By forecasting the supply chain, you can identify risks and mitigate them prior to conducting the trial. This will help to prevent making changes during trial conduct which can incur significant costs and increase timelines. With a well-forecasted clinical supply chain, you can include detailed consideration of trial design, or study-specific lead times, kit designs, country-specific challenges, and logistics associated with manufacturing, packaging, and distribution of supplies, particularly where product blinding is involved. 2. As-needed supplies and just in time deliveries A significant cost driver in clinical trials is product wastage. Without sufficient trial details including the number of participants, trial timeframes, product dosage and product expiry dates, it’s impossible to ensure the correct supply arrives at the trial sites at the right time. Packaging and labelling products on an as-needed basis and using a just in time delivery solution helps to reduce unnecessarily high levels of stock, avoid oversupply, and prevent having to make costly changes in the middle of trial conduct. 3. Implement a robust risk management process Risk management is an essential part of clinical trials to ensure you can generate a clear return on investment without disruptions. Each clinical trial has its own complexities based on the comparator, data, stock shortages which can delay timelines and increase costs. Mistakes can prove very expensive and more importantly, put patient safety at risk. The risk management process can be carried out in six clear steps from identification to reporting. While there may be some additional actions taken within the process such as time and resources, the benefit of having detailed risk management ensures your costs and data can be protected. 4. Bespoke sourcing strategies CSI will work closely with you to devise the most appropriate and cost effective strategy depending on the study design. i.e single country, multi-sites or multiple countries multi-sites, open label or double blind. Locally sourcing products in the same country as the trial helps to reduce costs associated with importing and exporting products out of the country, packaging and labelling. However it might not be the most appropriate for global studies. We have multiple options available to ensure the sourcing strategy is best suited to your study protocol. 5. Direct-to-patient distribution Delays and inefficiencies can equate to significant financial loss. If product acquisition is delayed, the window to package, label and distribute is shortened and there might be no medication available at the site for patients. Direct to patient distribution improves the cost-effectiveness of the comparator supply chain by increasing patient retention and compliance. Just in time deliveries enable immediate distribution in direct to patient trials, allowing for more deliveries, tighter deadlines, and fewer errors. Calculating shipping times and costs at the protocol design level enables supply chain managers to forecast the feasibility of the study and iron out design flaws before implementing them. Working with an expert comparator sourcing and clinical trial supplier like CSI ensures the most efficient and cost-effective supply chain helping you save money along the way and deliver your study on time and budget with minimum wastage.

In today’s global market, clinical trials are rarely isolated to one location Most clinical trials span many countries and regions, which requires comparator sourcing partners to have a global reach. Country-specific expertise and strong relationships with suppliers and manufacturers enable partners, like Clinical Services International (CSI), to source comparator drugs globally while maintaining regulatory compliance and maximising cost savings. Here are four reasons why having a global comparator sourcing network is beneficial: Identify opportunities for cost savings As a comparator sourcing partner, we use knowledge of global markets to choose the most appropriate sourcing strategy, whether it is local, central, market or manufacturing sourcing. By weighing up the appropriate strategies, we can identify where your company can save resources. For example, sourcing from the market that the trial is conducted in or sourcing products in one country and shipping for use in other countries. Typically, oncology drugs are less expensive to source in regions such as Asia and Latin America than in the United States or Europe. This is caused by the differential costs of local sourcing. On the other hand, exporting and importing comparators from emerging regions may bring with it higher distribution and logistical costs. Rather than sourcing comparators in established markets, we can source products from emerging regions and create cost-saving opportunities for your business. Remain compliant with regulatory requirements Regulations and legislation can differ greatly from country to country. When clinical trials are conducted in multiple countries, we need to be aware of the governing bodies and regulatory differences that may impact the conduct of the trial. This can include factors such as import, export, data, ethics and logistics. A global reach enables us to understand dynamic clinical trial approval processes, regulatory requirements and language barriers. We can obtain the right documentation, such as certificates of analysis, and translate it into the appropriate language that will successfully demonstrate the chain of custody from the source to the final destination. This avoids misinterpretation and ensures we maintain compliance throughout the trial process regardless of the participating countries. Substantial comparator availability Availability of comparator drugs in the United States or Europe can often be scarce. This is typically due to high demand and obstacles with the manufacturer limiting supply to the open market to keep product exclusivity. If this occurs, we often turn to other global markets to source the comparator product, where demand may be less and there is sufficient availability of the drug required for trial. Excellent relationships with audited suppliers, manufacturers and wholesalers across the world help us source products that would otherwise be unavailable in established markets. Our country-specific knowledge of regulations then enables us to identify whether the products can be exported and imported successfully, all while considering the trial design and logistics, such as product blinding. Delivery within the required timeframe When sourcing comparators from emerging regions, there is a risk that the product may not reach the trial site for use in the study within the product expiration date. This can be due to complications such as Brexit when gaining approval to import and export comparators into other countries. Using our global expertise, we can forecast the supply chain, communicate with local suppliers and manufacturers to overcome challenges, choose the appropriate strategy and deliver the product within the required timeframe. CSI is a world-leading comparator sourcing partner Working with a comparator sourcing partner like CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner. 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.

An effective comparator sourcing strategy requires the development of a robust supply chain, forecasting operations, distribution and logistics A comparator sourcing strategy has many moving parts. Ensuring all these parts work together requires comparator sourcing expertise to maintain product quality, safety and security standards. Clinical Services International (CSI) has over 25 years of experience in developing effective comparator sourcing strategies. We use our expertise to successfully plan and manage the comparator sourcing supply chain, to help shorten the supply chain process, minimise risk and maximise cost savings. Here are four steps to develop an effective comparator sourcing strategy. 1. Understand the trial protocol It’s important to take a step back and look at the bigger picture, to gather all the relevant information during the clinical trial supply planning process. We consider a list of initial questions when beginning a project to understand the comparator requirements. These questions include: Which comparator drug is required? What quantity of the comparator is required? Which countries are participating in the trial? Which documents are required for import and export? What is the delivery timeframe for the duration of the study? Is there a generic form of the comparator product available? After the answers to these questions have been considered, we can then choose the most suitable sourcing strategy, whether it’s using a local, central, market, manufacturer or hybrid approach. Choosing the most appropriate sourcing strategy ensures we stay within stringent budgets and timelines so the product and trial can be delivered successfully. 2. Forecast the supply chain to overcome risks Forecasting the supply chain helps to improve efficiencies, minimise risk and maximise cost savings. We forecast the supply chain based on the trial protocol to identify where risks may occur and the impact they have on the supply chain. This helps us put measures in place to prevent risks from occurring, ensuring they don’t affect the comparator, trial and data generated. We look at the different phases of the study and the complexities that arise in each stage. We then employ a 6 step risk management process - identify, evaluate, control, communicate, review and report – to ensure the supply chain is thoroughly considered and costs and trial data can be protected. 3. Leverage global network and supplier relationships Being unable to source the comparator product in the desired quantity within the trial timeline can prevent the trial from proceeding. Leveraging excellent relationships with audited suppliers, originators and dedicated wholesalers around the world allows us to overcome product shortages and unavailability on the open market. Working closely with suppliers and manufacturers helps us understand where there are challenges in the supply chain, such as logistics, quantity or expiry, and devise solutions to optimise them. Developing strong relationships ensures we gain intelligence about product changes well before they happen so we can always remain ahead of the market. 4. Choose the right comparator sourcing partner Developing an effective comparator sourcing strategy is challenging without the right team in place. By partnering with CSI, your comparator sourcing strategy 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 globally to ensure the successful supply of your clinical trials.

Here are three ways CSI helps you overcome challenges to ensure successful delivery of your clinical trial supplies Managing clinical trial supplies continues to be a challenge for companies in the healthcare and pharmaceutical industries. Amongst dealing with unpredictable lead times, restrictions on availability and trial delays, sponsors must consider the most appropriate strategies, to overcome challenges, save resources, and ensure trial success. CSI has over 25 years of experience in developing effective comparator sourcing strategies. We use our expertise to successfully plan and manage the comparator sourcing supply chain, to help shorten the supply chain process, minimise risk and maximise cost savings. There are many prominent challenges sponsors have experienced over the last few years, including expiry dates, COVID-imposed restrictions on comparator availability, stock wastage, and acquisition cost. Here are 3 ways CSI helps you overcome these challenges to ensure the successful delivery of your clinical trial supplies: 1. Balancing the risk of supply shortages against wastage The pharmaceutical industry continues to struggle with ongoing shortages of comparator drugs and investigational medicinal products (IMPs). Companies are increasingly pooling clinical trial supplies in fear of another nationwide lockdown or shipment delays caused by the pandemic and Brexit. With decentralised trials also increasing, companies are ensuring they have product overages to account for patients running out of medication. Pooled supplies and product overages can lead to wastage, which is a significant strain on financial resources. To avoid wastage, companies are accounting for a lower percentage of overage than they might usually. Minimising overage to only what is necessary, can reduce the number of products that go unused, therefore reducing product wastage. 2. Balancing comparator acquisition price against reliability The cost to acquire comparator products and IMPs is often high due to a competitive market, premium manufacturers' command for clinical trials, shipment delays and supply shortages. When choosing a comparator supplier, it’s important to consider the cost of the product while ensuring the reliability of the supply isn’t compromised. When comparator products are in limited supply, sponsors are often forced to pay retail prices compared to wholesale or local prices to secure sufficient supply, which can be very costly. Choosing a comparator sourcing partner that uses the best strategy for your trial design and comparator product will ensure you can maximise cost-effectiveness. A comparator sourcing partner will use local, market or manufacturer sourcing strategies based on the location of your clinical trial and available supply, to save you time and resources throughout the clinical trial supply chain. 3. Use trial forecasting to source products within expiry With lengthy lead times and delays in the clinical trial supply process, it’s common for comparator products and clinical trial supplies to surpass their expiration date before reaching the end of the study. When sponsors pool comparator products, have large overages or experience significant delays in the clinical trial supply chain, often the products can expire prior to being used in the trial. This can cause disruption to patient activities and result in relabelling activities at trial sites and distribution depots to extend the expiry dates on product supply. Sourcing partners must forecast the supply chain and understand the trial design to source and distribute products to the right place at the right time. This helps to reduce wastage, use products within the expiry dates, and save resources. Choose the right comparator sourcing partner By partnering with CSI, your clinical trial supplies and comparator sourcing strategy will take the most appropriate route to overcome challenges and improve the speed and agility of your 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. Contact us to discuss how we source comparators globally to ensure the successful supply of your clinical trials.

The clinical supply chain is a complex process involving not only logistics, but crucially compliance. How can this be maintained? The clinical supply chain is a complex process involving logistics and compliance. A clinical supply company must optimise their management processes to ensure compliance with local, national and international regulations. Maintaining compliance with the various regulations throughout the clinical trial supply chain is vital to the overall trial supply process. Clinical Services International (CSI) has extensive experience in clinical trials worldwide, which has led to expert knowledge of compliance in the clinical trial supply chain. These six tips will help you remain compliant with your supply chain. 1. Identify and manage risk Risk management protocols are essential for ensuring a smooth supply chain for clinical trials. You must address every compliance risk individually because each trial is unique. For example, each product must be kept within its specific storage conditions to remain effective and not present a health risk. It is critical to consider risks, even if they seem obvious. Due to the complexity of clinical trials, it is possible that regulations are not followed if proper risk management is not implemented. 2. Be aware of the complexity of regulatory requirements Imports, exports, data protection, and other regulations are different from country to country. Therefore, you need to carefully research the countries where the products are being transported to. When you have researched the regulations in each location, your clinical supply management strategy has nothing to hide if regulators inspect your processes. 3. Implement regulatory advice We have seen first-hand the challenges of complying with regulatory standards. Seeking advice from CSI can help you be compliant in the clinical trial supply chain. We offer: Certificates of Analysis (CofAs) Batch Release Certificates (BRCs) Statements of Authenticity (SoFaS) QP consultation CSI stays up to date on the latest regulatory developments and have built relationships with all major pharmaceutical manufacturers. Our trusted network of suppliers is fully audited and is fully compliant with regulations, such as the Falsified Medicines Directive (FMD). 4. Maintain excellent quality control The clinical supply chain must implement excellent quality control to maintain compliance since regulators can easily see discrepancies in the supply chain. Effective clinical supply management system that ensures appropriate systems are in place will reduce the risk of quality control falling below the required standard. For example, products must always be transported correctly. The FMD requires that there be a unique identifier code on the packaging to be scanned throughout the clinical supply chain. 5. Role of customs agents Exports and imports of clinical trial supplies must pass through customs and meet the regulations of each country. Therefore, in addition to doing your research, you may benefit from using local and international customs agents who can represent you at customs and process your declaration for you. The effectiveness of a customs agent in the clinical trial supply chain depends on the complexity and the volume of products that need to be transported - but they tend to be used with high volume, highly complicated supply chains. So, due to the nature of clinical trial supplies, using a customs agent can enable the products to be delivered in a timely manner. This will enable the clinical trials to run on time. CSI has extensive experience acting as an Importer of Record and working with local agents to facilitate all requirements and ensure smooth sailing. 6. Plan effectively The key to maintaining compliance in the clinical trial supply chain is to plan the entire process, as time and money can be saved with suitable organisation and having a reliable strategy. Aside from an effective plan being able to identify risks - as highlighted earlier, it also minimises the risk of not being compliant and having products held at customs, confiscated, or rendered ineffective. Overall, effective planning will help maintain compliance in the clinical trial supply chain. For further information, see our blog highlighting five reasons why clinical trial supply management is crucial. CSI implements strict operating procedures to maintain an excellent supply chain that ensures that all clinical trial supplies remain compliant. Contact us to see how we can help your clinical supply company meet regulatory standards in the clinical trial supply chain.

Direct to patient trials have surged in popularity in the wake of the coronavirus pandemic, offering several benefits to patients and clinical trials sponsors. Vanessa Dekou, Managing Director at Clinical Services International, reflects on the opportunities and challenges this creates for comparator sourcing partners. There’s little doubt that COVID-19 has disrupted the clinical trials industry, with many pharmaceutical companies reconsidering the best ways to reach patients, and so it’s no surprise that one outcome of the pandemic is the drive towards direct-to-patient (DtP) trials where possible. Many sponsors recognise the benefits of increased patient diversity, improved patient recruitment and retention, and reduced site visits, particularly for vulnerable patients with compromised immune systems. Logistics companies are keen to benefit from the increased demand – writing a lot of online articles extolling the virtues of DtP trials! – but what does this potential shift mean for comparator sourcing companies? How can they prepare themselves for a possible change in the landscape of clinical trials? From centralised bases to multiple depots In most instances, clinical trials are conducted through test centres – often hospitals – in various countries around the world, with one or more centralised bases supplying the centres. In such a model, the logistics of comparator sourcing and delivery are orientated around these supply hubs. In contrast, DtP trials rely on timely supply to multiple depots where an authorised distributor takes over the supply chain. This multiplication of delivery sites introduces a significant degree of logistical complexity and introduces a further ‘node’ in the cold chain. “Simplicity does not precede complexity but follows it.” Alan Perlis, computer scientist ‘Just-in-time’ deliveries Hospital sites or test centres often have the storage facilities to handle all the necessary drugs for the duration of an entire clinical trial, so may only need to receive two to three deliveries, simplifying the comparator sourcing supply chain. In contrast, authorised distributors in DtP trials are unlikely to have the capacity to store clinical trial supplies on-site to then be distributed over an extended period. Instead, DtP trials rely on multiple ‘just-in-time’ deliveries to depots, for near immediate distribution to patients. A comparator sourcing solution needs to allow for an increase in the volume of deliveries with much tighter deadlines and less margin for error. At CSI, this is nothing new; we have a wealth of experience in running oncology trials that can include over 30 different medicines, all requiring just in time delivery. These are generally open-label trials, and patients often self-administer the drug, so the products are sourced locally. Although this adds considerable complexity, we have all the necessary tools to manage supplies with an excellent success rate. Local versus international This move towards patient administration and in-country sourcing has eliminated the need to relabel the medicine or comparator. Yet this potential advantage is not without its downsides. Locally sourcing comparators poses challenges, such as limited supply and a non-competitive market, making it harder to meet a sponsor’s competing desires for convenience and reduced cost. However, at CSI we put patient safety first and, to do that, we work either directly with manufacturers or authorised country distributors to ensure continuity of medication. Efficiency is the primary driver Cost, however you spin it, is still a primary concern for any clinical trial sponsor, and we understand that. Local sourcing and DtP distribution can carry significant cost implications, although these may be offset by certain advantages such as increased patient retention and compliance. Working with an experienced comparator sourcing partner with an extensive database and well-established relationships with manufacturers and suppliers will be even more crucial than ever in helping to develop the most effective and efficient comparator sourcing solution.

Here are four ways CSI maintains quality assurance in clinical trial supply Maintaining quality throughout a clinical trial is an ongoing process that requires consistency and management. Having a robust quality assurance process ensures the relevant quality standards, regulations and guidelines are met in each clinical trial. What is quality assurance? Quality assurance is a systematic process of checks and analysis that determines whether the clinical trial supply is up to standard and meets specific requirements. Three of the most common regulations and codes of conduct that clinical trials must adhere to are the Falsified Medicines Directive (FMD), Good Distribution Practice (GDP) and Good Storage Practice (GSP). What is the clinical trial quality assurance process? The clinical trial quality assurance process involves all trial-related activities and documentation. Using the trial design, protocol and system of checks, the process examines whether the trial is conducted correctly, the data produced is reliable and accurate, and whether regulations including the FDA, GDP and GSP are adhered to. There are many challenges that can disrupt the clinical supply chain and the effectiveness of your study. To ensure the clinical trial isn’t deemed below standard, it’s important to forecast risks and identify solutions throughout the duration of the study. This ongoing, dynamic process requires your team to be aware of the challenges and how to mitigate them and maintain communication with vendors and partners so that the quality of the study isn’t compromised at any point in the supply chain. The quality assurance process is in-depth and covers a breadth of areas from trial design to delivery. These activities can include examining trial sites, auditing suppliers and vendors, ensuring correct packaging and labelling, and maintaining suitable storage and distribution conditions. This plan will also consider the study design, site and data management, and the final clinical study report (CSR). Auditing this documentation examines whether the data represented is accurate and reliable, and ensures the study is compliant with GDP, GSP and FDA regulations. 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 Our dedicated quality department’s sole function is to ensure that you receive the highest quality of clinical trial 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. 3. Global network Our global network of audited suppliers and manufacturers ensures we are compliant with regulations across the world. Our partners have local and regional market knowledge, regulatory knowledge, and are commonly part of the regulatory bodies themselves. Our partnerships ensure we know which processes to follow and how to best adhere to them. 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 covering 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 We also hold the IMP/MIA license, ensuring our quality management system is vigorous and robust. CSI is a world-leading partner in clinical trial supplies and comparator sourcing Working with an external clinical trial supplies partner can help to support your quality assurance process. Using our scientific ability and decades of experience in clinical trial and supply chain management, we implement robust quality assurance processes that ensure the integrity and accuracy of your study. By using our global network and strong relationships with audited suppliers, manufacturers, authorised distributors, and pharmaceutical wholesalers, we ensure your trial is compliant with differing regulations across the world.

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.