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Running a successful clinical trial means successfully managing the full clinical trial supply chain.
“Over the years, the clinical trial enterprise has been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilization of technology, data sources and innovations in design and conduct. The COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches…A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients.” - Former FDA Commissioner Robert M. Califf, M.D., 2023
In this 2023 call for recommendations around modernizing clinical trials, former FDA Commissioner Califf proposed the establishment of a functioning clinical trial supply chain. But an efficient clinical trial enterprise with adequate collaboration and sufficient utilization of technology does not spring fully formed from the aether. Major retailers like Amazon and Walmart spend years and millions of dollars streamlining their supply chains, cultivating in-house expertise, and developing the external relationships needed to keep them operating smoothly. How can the small teams overseeing clinical trial logistics modernize their trial operations?
A successful clinical trial hinges on smooth clinical trial supply chain management. Ensuring timely and accurate patient dosing while minimizing operational costs has only become more difficult as clinical trials become more complex and geographically dispersed. What are some best practices that can enhance your clinical trial supply chain management?
Successful trial outcomes rely on seamless collaboration between the teams running the trial. One of the primary challenges we observe in clinical trial management is a disconnect between clinical supplies and clinical operations teams. Such a disconnect between teams can lead to misaligned expectations and logistical inefficiencies.
One signal of potential conflict between teams is the language they use to describe their process. For instance, if a clinical operations team refers to a trial site as belonging to them (“my sites” or “our sites”), it exhibits an exclusionary mindset, and sets the clinical supplies team apart in a potentially adversarial relationship.
Clinical supplies and operations teams need strong collaboration along the entire journey of the clinical trial. They must align their goals and understand the impact of site performance on clinical trial supply chain forecasting. A collaborative approach can help both teams address challenges proactively and invest more deeply in the success of the trial.
Randomization and trial supply management (RTSM) technology plays a critical role in streamlining clinical supply chain processes, but even a built-for-purpose RTSM system like Endpoint’s is not an off-the-shelf panacea for logistical headaches. RTSM technology is only part of the solution. Setting up your RTSM to meet your needs requires careful, early planning and integration with your other eClinical systems. An RTSM partner with decades of experience supporting clinical trials, high-touch quality management, and tech-forward innovation is your hidden advantage for getting the most out of your RTSM system.
Here are a few best practices for implementing your RTSM system:
By standardizing processes and system functionalities, you can minimize the need for constant customization and ensure consistent performance across multiple trials.
Here are a few strategies for effective standardization:
Clinical trials are awash in uncertainties, from treatment efficacy and side effects to whether or not a patient’s insurance will cover the trial and if patients will adhere to treatment plans. Anticipating these potential risks and planning accordingly can help you avoid disruptions and ensure smooth trial operations.
Here are a few risk-management strategies:
Clinical sites play a crucial role in the success of clinical trials, and their experiences with technology and supply chain processes can significantly impact trial efficiency. Listening to site partners, incorporating site feedback into system design, and providing adequate training can all improve site compliance and data accuracy.
Here are a few ways to improve site engagement:
With expert knowledge of both software and trial protocols built on years of experience in the clinical trial space, choosing Endpoint Clinical as your RTSM partner can help you design an RTSM system that meets your needs and improves your clinical supply chain management. Working alongside your own in-house experts can ensure that your systems are designed to meet trial needs and can adapt to study changes seamlessly.
Reaching your trial endpoints hinges on successful clinical trial supply chain management–good planning, strong relationships with your sites, and leaning on your RTSM partner to get the most out of your RTSM system.
By bridging the gap between clinical supplies and operations teams, standardizing processes, leveraging expert insights, and incorporating site feedback, you can enhance trial efficiency and ensure successful outcomes.
The choices you make from the beginning of a study drive your success at every endpoint. By starting with Endpoint, you’ll have a layer of stability, support, and trust you can count on throughout your trial.
Schedule a demo with Endpoint Clinical to learn more about how our solutions can set up your clinical trial endpoints for success from the beginning.
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Master clinical trial supply chains—improve efficiency, reduce delays, and streamline study success.
