Global Industry Trends
How Is AI Entering Clinical and Regulatory Writing Workflows? The Role of Human Oversight in Current Industry Practice
Industry Example Publicly Described Practice
PPD／Thermo Fisher Scientific Uses AI-augmented workflows, AI agents, and AI assistants across clinical development, including AI agent- powered medical writing, while retaining expert SME oversight and human scientific oversight.
ICON Uses a secure AI tool to support automation and content improvement in CSR generation, patient narratives, and CSR plain-language summaries as part of its technology-enabled medical writing delivery.
Certara Integrates generative AI into CoAuthor for regulatory and medical writing, including protocols and CSRs, while explicitly maintaining a human-in-the-loop / human-at-the-helm model.
AlphaLife Sciences Uses AuroraPrime for AI-assisted regulatory and medical authoring across documents including protocols and CSRs, with source traceability, QC/review functions, and medical writers or regulatory experts retaining control through final approval.
The examples above are summarized from publicly available information provided by the respective companies. Company names may be linked to the original sources. These examples do not imply any partnership, agency relationship, or endorsement between these companies and Onea Clinical.
AI can accelerate information processing, content generation, and cross-document comparison. But the core of clinical and regulatory writing remains unchanged: whether the evidence supports the conclusion, and who retains responsibility for the final judgment.
Professional Insights
Onea Clinical Insights
Perspectives on clinical development, IND documentation, clinical project management, and the practical role of AI in development workflows.
Onea Clinical is the clinical development professional services business of Onea Biotech Co., Ltd.
AI-Assisted Production · Clinical PM Integration · Human Professional Review
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