RBM Toolkit: Top 10 Core Key Risk Indicators

Data capture is no longer the bottleneck, and whether the lag between a signal and a decision shrinks depends on signal design, AI governance, and vendor orchestration.

In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.

The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.

What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, explains why the real advantage of faster data isn’t speed—it’s shortening the distance between signals, human judgment, and the next best action.