At the 2023 Interactive Response Technologies (IRT) Conference in Boston, Susan Vong, President and Founder of Poxy Clinical, and Dia Lawson, Senior Manager, Clinical Supply Chain at Sumitomo Pharma America (SMPA), met for a fireside chat, where they discussed the intricacies of user acceptance testing (UAT) and shared insights and lessons learned from their collaboration on clinical trials.
Both speakers highlighted the importance of collaboration and a commitment to prioritizing UAT in building a strong partnership. When clinical supplies teams are tasked with performing UAT, they often lack adequate training and are burdened with having to conduct UAT on top of their daily responsibilities. A compelling example showcased the potential consequences of overlooking high-risk test scenarios during UAT, relating to subject dosing parameters. In the example, a dosing error ultimately affected the entire study population and caused patient safety concerns once the study build moved to production.
Such errors not only affect patient safety but also have implications for the clinical supplies team; by implementing higher doses across the board, these errors can cause limited drug stocks and system reprogramming and impact site relationships and the study timeline. A partnership with a third-party UAT provider can help prevent these outcomes from occurring by discovering such errors prior to system go-live.
Susan and Dia outlined four key best practices for a successful UAT process, supplemented with examples from their work together.
Susan and Dia’s fireside chat provided a valuable insight into the complexities of UAT in clinical trials. Their insights, ranging from building robust UAT processes to navigating challenges and implementing best practices, serve as a valuable guide for industry professionals aiming to enhance the efficiency and effectiveness of their UAT processes. The lessons learned from their collaboration underscore the importance of continuous improvement and a proactive approach to UAT in ensuring the success of clinical trials.