In this episode of Clinical Trial Files, we’re joined by Akanksha Jain, a clinical research quality and data professional with deep expertise spanning biostatistics, data management, risk-based quality management (RBQM), and trial oversight.

Akanksha shares her career journey from a strong foundation in statistics into clinical research, offering a unique perspective on how data, quality, and operational decision-making intersect across the clinical trial lifecycle. She explains why quality cannot be an afterthought—and how embedding risk-based thinking early in study design leads to stronger outcomes, better compliance, and fewer downstream issues.

The conversation explores practical applications of RBQM, centralized monitoring, and data-driven oversight, along with common misconceptions about quality roles in clinical trial ...