As drug supply managers, our main goal is to have enough drug in the supply chain throughout the lifecycle of a clinical trial. However, this is often a multifaceted and complex challenge. What is enough? Enough where? Enough according to whom? Enough when? In supply management, we aim to have the confidence that our current plan will sufficiently provide the entire study with the materials it needs without introducing any unnecessary risk into the supply chain.
At 4G Clinical, we understand there are many ways to calculate demand and supply, but what the industry needs is an accessible tool that helps supply managers optimize their supply plan based on known information for the trial at hand. Many pain points supply managers deal with often sit in three areas: answering ‘what-if’s, planning depot transfers, and planning production operations. Although, many times supply managers won’t have all the answers, they want to understand the impact of both study changes and their operational decisions on the supply for the study.
Drug supply professionals must be able to understand the impact of those “what-if” scenarios. What if enrollment changes? What if the country start dates change? What if we add new depots? What impact do the new protocol changes have on the current inventory? Thus, having access to a commercial tool that makes updating scenarios simple can not only reduce the anxiety these challenges bring but also make getting to these answers less time consuming to set up.
Another key challenge for supply managers is understanding the timing and quantities for both depot transfers and production planning. The tools you use for forecasting should help enable you to calculate how much drug needs to be sent to each depot. This is something that can change frequently depending on the site and patient demand and is directly impacted based on the risk tolerance of the drug supply manager. Forecasting tools need to make the process of updating a few parameters in a scenario seamless, and the output must clearly show the supply manager how much drug will need to be transferred and how long that drug will last for the downstream sites and depots.
Production operation planning could be considered an art and not a science. Like our previous two pain points it is often dependent on risk tolerance, and the limited information we are provided at the time. The hope is that your tool gets out of the way and helps to create a production plan based on the information that it is given. Asking a simple question like, “How much do I need to produce and when does it need to be released?” should be an easy question to answer.
At 4G Clinical, we help drug supply managers take the information they are provided and produce answers beyond these three areas. Our forecasting tool can help drug supply managers to optimize their supply plans, and quickly produce outputs that help facilitate efficient decision-making around the questions posed from other departments within your sponsor organizations.
Casey Ferrier brings 14+ years of experience in the clinical trial supply industry to 4G Clinical. He has implemented and led supply chain strategies to deliver solutions that support packaging, distribution, and logistics requirements for clinical trials for Pharma, Biotech, and CRO organizations. Casey also spent...