Pandemic experiences highlighted the need to address trial supply challenges

Clinical trials are the backbone of medical research, serving as a key bridge between drug development and patient care. As we have discussed in our previous reports, clinical trials are expensive and time consuming, and any delay pushes out the timeline for potential approval, meaning lost opportunities to improve patients' lives and unrecoverable revenue. Supplying clinical trials with trial therapies, or investigational medicinal products (IMPs), is a pivotal part of the clinical trial process that can affect trials' success, cost and speed. The critical nature of clinical trial supply management became especially apparent during the pandemic, which highlighted supply chain weaknesses in areas such as third-party logistics, forecasting, inventory visibility and staffing. With this in mind, pharmaceutical companies are increasingly turning to technology-based solution providers to handle some or all of their clinical trial supply needs.

Multiple pain points in supplying clinical trials

Clinical trial supplies are the investigational medicinal products and other materials and equipment needed to effectively conduct clinical trials. This includes everything from drugs being tested to patient biological samples to the packaging and labeling used in moving them from one location to another. Managing clinical trial supplies involves a range of activities, from planning and forecasting to procurement and distribution. Clinical trial supply chains are deeply interconnected. Expected enrollment levels at trial sites affect supply and logistics decisions made upstream. Unfortunately, most teams throughout the process work in silos, making clinical trial supply management extremely complex and difficult with challenges that include managing inventory levels, ensuring timely delivery of investigational drugs, and maintaining regulatory compliance and patient safety.