Japan’s pharma and CRO ecosystem lacks clear governance for generative AI use in clinical trials, according to a new study surveying industry participants. Researchers found that only 60% of Japanese CROs have governance documents for AI use and just 6% have standard operating procedures covering generative AI in clinical studies. The gap creates uncertainty for data security, compliance, and human oversight, especially compared with more explicit guidance from the US FDA, EMA risk-management framing, and WHO updates. The authors argue for formal frameworks plus practical education and training. Separate signal from the diagnostics side: Guardant Health’s FDA companion diagnostic approval for zongertinib reinforces how AI-adjacent technologies (like liquid biopsy workflows) are becoming embedded in regulated decision pathways.