Generative AI regulatory-document solution with Hitachi

Shionogi said a generative-AI solution for drafting regulatory documents in drug development was built by combining its medical writers' knowledge and its data scientists' AI design work with Hitachi's generative-AI know-how. A proof of concept at the company confirmed about a 50% reduction in clinical study report preparation time and about a 20% reduction in protocol preparation time. The same release says Shionogi licensed the solution to Hitachi, which began offering it to pharmaceutical and healthcare companies in Japan in February 2026.