JapanHealthcare and life sciences2025 – ongoingShionogi
Generative AI drafting of clinical study reports and trial protocols
Shionogi's AI drafting pilot cut study-report preparation time by about 50% in a reconstruction exercise
Problem
Medical writers had to turn extensive clinical-trial information into specialized regulatory documents. Preparing these documents required substantial manual work and scientific accuracy.
Approach
Shionogi and Hitachi developed a tool that extracted and summarized trial information in Japanese and English and generated initial drafts. Shionogi tested it by recreating a past clinical study report and preparing a protocol for a new trial. Hitachi began offering the licensed solution in Japan in February 2026.
Results
Takeaway
The report result came from reconstructing an existing document; the protocol result involved a new trial. Neither figure established a reduction in the full drug-development timeline.
Categories
- Industry
- Healthcare and life sciences
- Business function
- IT and R&DInternal work and knowledge management
- Innovation type
- Process innovation
- AI technology
- Generative AI
- Adoption
- Partner co-development
- Evidence
- Vendor case study
Sources
Source summaries
Hitachi reported Shionogi pilot reductions of about 50% for study-report preparation and about 20% for protocol preparation. The report exercise recreated an existing document, while the protocol concerned a new trial. Hitachi also announced commercial availability in Japan.
Full details are in the original sources.
