We provide world-leading, bespoke clinical trial supply chain solutions
Clinical Services International (CSI) delivers best-in-class clinical trial supply solutions by developing tailor-made sourcing strategies for our partners, carrying out proactive project management, and ensuring the timely and efficient distribution of medicines and medical devices.
When procuring medicines and ancillaries for our partners’ clinical trials, we know that delivering the right sourcing strategy can yield massive savings. Our unparalleled access to products manufactured around the world and our logistical capabilities mean we have never failed to deliver to a study.
Medicines and Ancillaries
Storage and Distribution
Project Management
Medicines and Ancillaries
Comparator Drug Sourcing
At CSI, we take a scientific approach to comparator sourcing based on our 25 years of experience in the clinical trial supply industry. Comparators are on the critical path of almost all clinical studies but are increasingly expensive and hard to find. We pride ourselves on finding the unfindable, sourcing comparator drugs that allow clinical trials to run on time and provide better patient outcomes.
The clinical supply partner of choice
Pharmaceutical companies, biotechnology companies and Clinical Research Organisations (CROs) must have robust comparator sourcing strategies in place to ensure that comparator drugs are supplied to all clinical trial sites at a competitive price and without disruption. CSI has supplied medicines to over 1,000 clinical trials across lifecycle phases 1 to 4, supporting our partners with even the most complex and challenging requirements.
We understand that every clinical study is different and requires a customised approach. With the experience to take on even the most complex adaptive trials, we know how to reduce complexity and drive value, delivering sourcing strategies to improve the speed and agility of your study.
CSI delivers results with:
A comprehensive understanding of clinical trial requirements and protocols
Fully bespoke sourcing solutions, whether country-specific, global or hybrid
A global network of qualified suppliers, manufacturers and wholesalers
A wide range of suppliers to minimise risks and enable sourcing of specific batches
Full documentation, client support and supply chain transparency
CSI’s six drivers of effective comparator sourcing
Understanding the science behind a clinical trial informs CSI’s efficient supply strategies
Protocol interpretation
Protocol interpretation
Product access
Product access
Supply continuity
Supply continuity
Cost control
Cost control
Speed
Speed
Supporting documents
Supporting documents
graph
Our most frequently supplied comparator medicines
Humira
adalimumab
Arthritis
Eylea
aflibercept
Ophthalmology
Tecentriq
atezolizumab
Oncology
Bavencio
avelumab
Oncology
Avastin
bevacizumab
Oncology
Yervoy
ipilimumab
Oncology
Abraxane
nab-paclitaxel
Oncology
Opdivo
nivolumab
Oncology
Ibrance
palbociclib
Oncology
Keytruda
pembrolizumab
Oncology
Lucentis
ranibizumab
Ophthalmology
Stivarga
regorafenib
Oncology
Mabthera
rituximab
Oncology
Jakavi
ruxolitinib
Oncology
Talzenna
talazoparib
Oncology
Roactemra
tocilizumab
Arthritis
Branded Name
Scientific Name
Indication
Overcoming the challenges of comparator drug sourcing
The sourcing of comparator drugs and non-investigational medicinal products (NMPs) has become increasingly critical as most drugs are now tested against the standard of existing care. Despite market growth and development, it is becoming more difficult to guarantee the timely availability of comparator drugs due to many of the products being biologic medicines, which are difficult to produce and distribute.
Working with CSI will streamline your clinical trial supply chain and ensure high-quality comparator drugs are sourced in a timely and cost-effective manner. Our scientific expertise means we can advise on new investigative drugs and, with our global reach and emphasis on quality, you can always rely on us to deliver.
Comedications
The standard of care for many indications, especially in oncology, is now a combination of drugs that together provide maximum efficacy. Comedications may be used to alleviate side effects or to improve the potency of the treatment. Comedications are common in cancer treatment because of the multitude of biological mechanisms at play in disease progression. Combination therapies play a crucial role in the comprehensive care of patients, from managing risks to creating synergies that give the gold-standard of treatment.
Critically, for clinical trials, the increasing prevalence of combination therapies being used as comparators means more complexity and greater risk from delays, drug shortages, disruptions and compromised supply chains. Securing multiple products on time, and in the right condition, is even harder when each requires a different supplier and logistics solution.
CSI has the expertise and experience to help our partners to overcome these challenges. Our scientifically-minded team has the knowledge to advise on the optimal sourcing strategy for all comedications and combination therapies that might be required for any trial, factoring in origin of supply, price, logistics and shipment timing.
Medical Devices and Ancillaries
As well as medications, clinical trials often require a wide variety of ancillary supplies, including medical devices, technological equipment, disposable products and print materials.
At CSI, we apply our sourcing capabilities, logistical expertise and robust quality standards to ensure that all essential supplies reach trial sites in a reliable and cost-effective manner, no matter their location.
Leveraging our partnerships with leading manufacturers, we can offer significant cost savings on medical devices and ancillaries required to support our partners’ clinical trials, including:
CSI’s ancillary services include the rapid delivery of
Electrocardiogram
(ECG) tests
Spirometers
Weighing scales
Blood pressure monitors
Infusion pumps
Cooled or uncooled
centrifuges
Refrigerators
Medical equipment
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Electrocardiogram (ECG) tests
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Spirometers
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Weighing scales
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Blood pressure monitors
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Infusion pumps
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Cooled or uncooled centrifuges
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Refrigerators
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Freezers with temperatures ranging from -20°C to -80°C
Technological equipment
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eDiaries
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Mobile devices
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Laptops
-
Printers
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Pill splitters
Print materials
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Investigator site files
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Pharmacy binders
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Patient recruitment material
Download our Ancillaires brochure
Storage and Distribution
CSI has delivered comparator medicines, medical devices and ancillaries to thousands of clinical trials around the world. Our extensive experience and global reach mean we can advise our partners on the best strategy for supplying any study – whether this involves direct-to-site shipments, local or regional depots, or hybrid solutions – to ensure the necessary products arrive on time, within budget, and at the required location.
We understand the challenges of managing a complex clinical trial supply chain and can deliver to your site, warehouse or packaging agent. CSI’s integrated, end-to-end distribution solutions allow our partners to maintain focus on the drug development process, keeping studies flexible, agile and on schedule.
Delivering for our partners
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Our Global Reach
Warehouses and offices
Our network extends to 60 countries on six continents
Rescue Studies
We apply our same expertise, global footprint and operational excellence in service of global studies that may need rescuing, whether this relates to issues of procurement, sourcing, resource, compliance, quality or timelines. With CSI’s decades of experience in the clinical trial supply industry and dedicated client relationship managers, we are here to help you get your study back on track.
CSI has sourced rescue medications for a range of global studies, including the supply of infliximab, salbutamol, ruxolitinib and mycophenolate motefil.
Global expertise with unrivalled global knowledge
CSI is headquartered in London and has offices in the United Kingdom, United States, Germany and Israel. Delivering clinical trial supplies to some of the world’s most difficult-to-reach markets, our experienced and knowledgeable teams have comprehensive knowledge of import and export logistics, as well as the movement of investigational medicinal products (IMPs) across all global markets. Our international reach ensures we can source the clinical supplies needed for even the most complex trials and deliver them on time and within budget.
We overcome distribution challenges
CSI’s flexible clinical trial supply strategies ensure we can overcome any distribution challenges that might affect the outcome of our partners’ clinical trials, including:
Breakdowns in the logistical supply chain
Slow-paced patient recruitment
Resource availability
Fluctuation in demand
Expiring batches
Our clinical distribution strategy covers logistical planning, imports, exports and inventory shelf-life control, and our centralised compliance team oversees the entire study. This reduces vendor complexity and ensures clinical supplies are delivered within the agreed timeframe.
We value clear communication
Throughout the clinical trial supply process, CSI implements study-specific systems to update and communicate clearly and regularly with our partners and supply network, so all parties are kept informed of the status of clinical trial supplies. To aid transparency and efficiency, each of our partners is assigned a dedicated project manager from CSI who is responsible for overseeing the project from the proposal stage to delivery.
Identify
Evaluate
Control
Communicate
Review
Report
Strategically positioned global depot network
International clinical trials require global facilities in strategic regions combined with local insight and experience of a variety of regulatory requirements. CSI’s global depot network spans 60 countries and six continents, allowing us to identify the most cost-effective solutions for any trial supply, while maintaining flexibility and allowing for contingencies.
Secure shipment tracking
All CSI warehouse and shipment activities are tracked using GPS and our specialised inventory system, so we are always in control of our stock levels and can guarantee full traceability from pick-up until delivery. We provide partners with full visibility throughout the logistical process, and our tracking system efficiently flags low stock levels and impending expiry dates. We can also provide, as required, customised inventory reports that document:
Materials
Tracking numbers
Shipment and receipt date
Serial numbers
Batch numbers
Temperature records
Materials
Tracking numbers
Shipment and receipt date
Serial numbers
Batch numbers
Temperature records
CSI has over 25 years of experience in developing effective comparator sourcing strategies. We use our expertise to successfully plan and manage the entire sourcing supply chain, helping to simplify the supply process, minimise risk and maximise cost savings for our partners. With our service-orientated approach, our partners benefit from a dedicated relationship person and ongoing support and problem solving at every stage of a project.
There are many moving parts and unpredictable factors at play in clinical supply chains. With CSI’s specialist project management and logistical expertise, we understand the complexities involved in planning and managing clinical trial supplies and strive to mitigate any risks that might prevent our pharmaceutical, biotechnology and CRO partners from operating at maximum efficiency.
We have never failed to deliver to a study
Project Management
Protocol and
market analysis
“A scientific approach to clinical trial supply”
An effective clinical supply management strategy begins with the comprehensive understanding of a trial protocol. This is where CSI’s 25 years of scientific expertise sets us apart from other clinical trial supply companies, allowing us to provide the best possible advice on the most efficient and cost-effective sourcing strategy for any study.
Analysing trial-specific factors such as the required medications, ancillaries, quantities, locations, documentation, timeframes and the availability of generics, allows CSI to present an optimised local, central, market, manufacturer, wholesaler or hybrid sourcing strategy. With experience of shipping to even the most remote countries around the world, we offer expert regulatory guidance, can anticipate global supply challenges, and develop custom supply solutions for our partners.
Direct-to-site delivery
For open label studies, CSI can deliver directly to sites in a fast, reliable and cost-effective manner. We work closely with project managers, assisting with trial forecasts to ensure that medication is available at all sites when needed. Our flexible and adaptive solutions help our partners to save resources and facilitate effective patient recruitment and retention.
CSI’s six steps for effective risk management
Controlled transport and storage
CSI is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Berlin State Office for Health and Social Affairs (LAGeSo). We are experts in cold chain biologic, temperature-controlled and ambient product delivery, and our quality management system ensures full compliance with regulatory requirements around the world. All our depots are audited to ensure the highest standards of Good Manufacturing Practice (GMP), while our end-to-end transport and storage services are monitored at every stage of the distribution process.
CSI carries out comprehensive scenario planning from the protocol analysis stage onwards. Once a clinical trial is underway, we regularly review forecasted supply requirements against actual drug use to minimise wastage and unnecessary costs. We can also pool inventories for study programmes to reduce waste and to save money for our partners.
CSI reduces complexity and adds value by:
on the resourcing and project management level
Maximising efficiency
and overage of medicines and ancillaries
Minimising wastage
such as European products into the United States
Importing medicines
for frequently used medicines
Centralising purchasing
and timelines for packaging and labelling
Minimising lead times
against the supply cost balance
Optimising shipping costs
according to specific project needs
Ensuring consistency and reliability of medicines
of resources, access to suppliers and logistical partners
Maximising flexibility
Qualified Person and regulatory services
All Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a clinical trial. CSI’s respected and well-established quality department has in-depth experience across a wide range of product types and dosage forms, and ensures regulatory compliance across all of our international operations.
Sourcing and distributing medicines and medical devices globally requires extensive knowledge of regional regulations that differ from country to country. CSI’s regulatory and quality assurance experts have longstanding relationships with MHRA and EMA and can provide advice and solutions for our partners’ clinical trial supply needs. Since documentation is often necessary for import and export purposes, all our products are delivered certified.
By conducting thorough and proactive quality control checks throughout the entire supply chain, CSI identifies and mitigates any quality issues before they come to fruition, while the depth of our regulatory knowledge allows us to foresee potential roadblocks in the supply chain so we can resolve issues in a timely and efficient manner.
Supply planning and risk management
An effective comparator sourcing strategy requires robust forecasting to maximise supply chain efficiency and minimise potential costs for all parties. Thorough forecasting involves identifying the potential risks that might arise at each phase of a trial – including fast or slow patient recruitment; availability, expiry and batch requirements of a medication; potential drug shortages or fluctuations in global market price and demand – and the impact these might have on the clinical supply chain, before ensuring that necessary contingency measures are in place to protect budgets, timelines and, ultimately, trial data.
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements
Contact us
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