Automating the IRT Process for Temperature-Monitored Shipments

This case study outlines how Grünenthal collaborated with Suvoda to automate the Integrated Response Technology (IRT) process for temperature-monitored drug shipments. Historically, the manual management of temperature excursions resulted in delays of up to 29 days, during which drugs were quarantined, risking patient access and potential shortages. The partnership aimed to streamline this process by integrating various systems, including Suvoda IRT, Catalent's depot network, and Berlinger's data loggers. The solution involved normalizing data models and ensuring compatibility among different systems. Post-implementation, a pilot study across 50 sites demonstrated significant improvements, reducing the manual process to a same-day solution and achieving an 89% reduction in automatically quarantined shipments. The results indicate that automation can enhance visibility and compliance with World Health Organization guidelines for temperature control, showcasing the potential for further automation in clinical trials to improve efficiency and patient outcomes.