Pharmaceuticals and biotech / Pharmaceuticals
Shionogi: Generative AI drafting of regulatory documents such as clinical trial protocols and clinical study reports
- Company
- Shionogi
- Country
- Japan
- Adoption stage
- Pilot
- Source published
- Date basis
- The date the source was published. It can differ from the date adoption started.
- How the source was checked
- Read the full source text
The work problem
According to a press release Shionogi issued on February 24, 2026, preparing regulatory documents such as clinical trial protocols and clinical study reports usually takes 3 to 5 months in drug development and creates an enormous workload centered on the medical writers who lead the writing. The company said improving the efficiency of this work is an important issue that determines the speed of drug development.
Technology and data
Shionogi developed a solution that supports the writing of regulatory documents by combining the expertise and practical experience of its medical writers and the data and AI design skills of its data scientists with Hitachi's know-how in using generative AI. The solution extracts key points from vast clinical trial data that mixes Japanese and English and automatically generates first drafts of regulatory documents. Shionogi signed an agreement to license the solution to Hitachi, and Hitachi began offering it to pharmaceutical and healthcare companies in Japan in February 2026.
Results
In a proof of concept Shionogi ran in house, the time to write clinical study reports fell by about 50% and the time to write clinical trial protocols fell by about 20%. The company said the solution will greatly streamline document writing and ease the burden on frontline staff, and that it aims to create an industry model case for delivering medicines to patients sooner.
Limits and open questions
The press release does not give the number of documents covered in the proof of concept, the measurement method, or how much people revised the AI drafts.
Sources
- 塩野義製薬と日立、生成AIを活用した医薬品開発の規制関連文書作成支援ソリューションを提供開始ー治験関連文書の作成時間を最大50％短縮し、医薬品開発の効率化を推進shionogi.com, Accessed
Compiled from public sources. These are not results from ATF Works customers.