Loftware’s Prisym 360 software is an innovative label and content management solution that incorporates industry best practice and is designed specifically to meet the complex regulatory requirements essential for clinical trial labeling. The information that accompanies clinical trial products is essential in ensuring their safe and effective use by patients and healthcare professionals. As the number of countries included in each study can be extensive (with each having specific regulatory content, phrase and language requirements), so the process of designing and printing booklets takes more time and effort, leading to greater risk of error. Prisym 360 is a validation ready cloud-based label printing platform that is simple, standardized and scalable. Its unique features include automated booklet design, phrase and translation management, integrated change request and approval workflows, and flexible on-demand/Just-in-Time (JIT) print models. In addition, the integrated vision print inspection simplifies, automates and reports in real-time on both the content and design of every printed label. Designed, tested, and delivered with a full validation documentation pack, Prisym 360 provides certainty that labels and booklets are produced accurately, efficiently, and compliantly to support today’s complex, adaptive clinical studies.