As clinical trials become more complex in design, seek to include varying populations and reach patients around the world, having a robust end-to-end supply chain solution is vital to ensure investigational drugs are readily available at clinical sites when needed.
To help build a robust clinical supply chain that supports global trials effectively and efficiently, key areas to consider include:
Demand Forecasting and Planning
A crucial starting point is to have an understanding of the trial protocol and patient enrolment projections to estimate the demand for the investigational drug. Factors such as trial duration, patient recruitment rates, dosing schedules, and geographical distribution should be considered. In addition, factors related to the study drug such as manufacturing schedule and quantities, dating period and stability program, and kit design should also be considered. Working closely with internal clinical teams and external partners such as contract research organizations (CROs) and your partner contract development and manufacturing organizations (CDMOs) are important for gathering accurate information for demand forecasting.
Global Sourcing and Procurement
With the major upheaval in supply chains over the past number of years, global sourcing and procurement have been in the spotlight. Disruptions to the pharmaceutical supply chain vary in severity, frequency and lead time – and they happen regularly. Identifying reliable suppliers for raw materials/APIs, packaging materials etc and working with global CDMOs with a local presence in your clinical trial territories will help secure your supply chain. The criteria for evaluating suppliers should be based on their quality, reliability, regulatory compliance, and ability to scale-up to meet global clinical demand and ultimately commercialization.
Manufacturing and Packaging
Factor in your clinical supply strategy. Whether you are manufacturing and packing your clinical supplies in-house or partnering with a global integrated CDMO you should ensure your processes have the flexibility to quickly respond to unplanned events that will occur during the trial. Variations from planned enrolment rates or geographies, catastrophic loss of inventory, or interruptions in the supply chain will necessitate creative solutions. Packaging strategies should also be flexible to accommodate issues that arise.
Distribution and Logistics
Develop a distribution strategy that not only ensures timely and compliant delivery of investigational drugs to trial sites worldwide, but maintains the integrity and safety of your drug products throughout the supply chain. Your chosen distribution partners should have expertise in global shipping, customs regulations, and cold chain management if applicable for temperature sensitive drug products.
It is also important to think about global logistics and the countries where you will launch your new compound. For instance, assessing international regulations and the importation and exportation of a clinical trial medication in terms of time and cost, which will eventually be part of the commercialization plan.
Implementing an efficient inventory management system to monitor stock levels at different sites enables the optimization of production and distribution strategies for efficient and robust clinical supply management. Utilizing advanced inventory technology facilitates data driven planning to help prevent stockouts and overstock situations, ensuring clinical supply matches patient demand.
Application of technologies such as Late Stage Customization (LSC) and Just-in-Time (JIT) supply models provide a streamlined approach, minimizing waste and loss, optimizing inventory, and furthermore enabling a more nimble supply capable of adapting to changing clinical demands. Given the ever-increasing high value of medicines, particularly for rare diseases and indications such as oncology, this is important in getting vital medicines to patients around the world.
Stay informed about the regulatory requirements and guidelines for clinical supply chain management in different regions. Ensure that requirements for the supply such as label text and release as well as all activities from sourcing to distribution comply with the relevant regulations (e.g., Good Manufacturing Practices, Good Distribution Practices, local regulations).
Proactive supply chain analysis and scenario planning is needed to address questions such as; what would happen if an unplanned event was to occur at an existing supplier? What impact would a natural disaster have on supply chains? If there was a surge in demand, could the existing supply chain model absorb it? What risk control and mitigation plans are in place to prevent drug supply disruptions and shortages of critical medicines?
In line with regulatory authority guidance to help prevent drug shortages and as good practice, potential risks should be identified and contingency plans proportional to the impact should be established to address supply chain disruptions. Risk management plans should be reviewed and updated regularly based on changing circumstances.
Communication and Collaboration
Fostering open communication between different internal departments, including clinical, regulatory, supply chain, and quality assurance will assist in optimizing the clinical supply management process as drug products progress through the development lifecycle and will ultimately aid planning and preparation for launch. Collaborating closely with CROs, clinical sites, and CDMOs will also ensure responsiveness and alignment on supply chain needs. Creating communication plans that document the individuals involved from the various departments and companies with escalation routes and blinding levels will help in creating and maintaining open communications.
Technology and Data Integration
Implementing advanced technologies such as supply chain management software, IXRS systems, data analytics, and AI will optimize supply chain operations. Integrating data from various sources will enhance operational visibility, aid decision-making and bring efficiencies. The more you can refine your future plan based on actual real-time data, the quicker you can react to changes and the more predictable your supply chain can become.
In the fast-paced world of clinical trials nothing stands still. To help build a robust supply chain that supports your global trial you should regularly assess the performance of your clinical supply chain and identify areas for improvement.
PCI Pharma Services – Your clinical trial destination. Our world.
PCI is a leading global CDMO, truly spanning the cycle, connecting development and commercialization, de-risking the supply chain providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success.
We provide a global service with localized focus, delivering over 200 protocols a year in over 100 countries, utilizing best-in-class technologies combined with our experienced and dedicated teams. Our global network of innovative centers of excellence across Asia Pacific, Europe, North America and Canada provide a seamless service, supporting the global supply of investigational medicines with pharmaceutical development, clinical drug product manufacturing, packaging, labeling, storage and distribution and full returns service.
PCI Clinical SMART (Supply Management And Readiness Team) offers the expertise to foresee and plan ahead to overcome hurdles experienced during the clinical lifecycle. SMART Clinical Supply Managers have the expertise to manage single trials or entire clinical programs with support that can be customized to meet specific study requirements and adapted as the trial progresses. Providing dedicated experienced project management with end-to-end capabilities from protocol development, establishing processes and SOPs to study close adds robustness to your supply chain.
At PCI, we embrace a digital-first mindset and leverage industry-leading technology. Our digital supply chain management platform pci | bridgeTM, is built to deliver an industry-leading customer experience, unlocking productivity with access to real-time supply chain information and digital workflows. The innovative technology is designed to provide accessibility to production and distribution status, open invoicing and inventory information, documentation approvals and easy reporting features. Providing real-time supply chain visibility using cross-functional workflows and data-driven insights ensures milestones are met throughout the product lifecycle, supporting clinical and commercial supply chains alike.
Although supply-chain risks are unavoidable, biopharmaceutical companies can minimize their disruptive effects through greater visibility, rigorous risk management, and utilizing newer technologies that help companies better anticipate and respond to shocks. At PCI, our consultative and flexible approach combined with scalable integrated clinical supply solutions across drug product manufacturing and packaging, ensures the optimization and security of clinical trial supply chains, helping to mitigate risk and deliver overall trial efficiencies.
Building Robust Clinical Supply Chains to Support Global Trials by Edward Groleau | As seen in The Journal for Clinical Studies | October 2023.