Revvity Signals CEO Simone Sharma says Phase III trials are generating millions of data points, while the industry’s approval output has not kept pace with R&D spend, pushing sponsors to rethink how clinical data are reviewed. The piece highlights AI-enabled clinical oversight focused on medical review workflows such as AI-assisted listing generation and signal detection, aiming to accelerate turnaround without losing traceability. The article frames AI not as a replacement for governance, but as an augmentation for regulated oversight—specifically continuous monitoring of safety, data quality, and protocol adherence across complex, multi-site global trials. It also emphasizes that adoption depends on trust, governance, and documented accountability. Sharma argues that manual clinical programming review can become a bottleneck, and that shifting low-level tasks to AI can let medical monitors and data managers focus on higher-value review. The overall message is that sponsors will need to operationalize AI governance to satisfy regulatory expectations while scaling oversight to new trial data volumes.