We have never failed to deliver to a study
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.
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.
Supply planning and risk management
An effective comparator sourcing strategy requires robust forecasting to maximise supply chain efficiency and minimise potential costs for all parties. Thorough forecasting involves identifying the potential risks that might arise at each phase of a trial – including fast or slow patient recruitment; availability, expiry and batch requirements of a medication; potential drug shortages or fluctuations in global market price and demand – and the impact these might have on the clinical supply chain, before ensuring that necessary contingency measures are in place to protect budgets, timelines and, ultimately, trial data.
CSI’s six steps for effective risk management
Identify
Evaluate
Control
Communicate
Review
Report
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.
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