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 trials. Akanksha also discusses the evolving expectations under ICH E6 (R3), including proactive risk identification, cross-functional collaboration, and the growing importance of analytics in sponsor and CRO decision-making.

Listeners will gain insight into how quality professionals can move from reactive issue management to strategic partners within clinical development teams—and how early-career professionals can build the skills needed to thrive in an increasingly data-centric research environment.

This episode is a must-listen for clinical research professionals interested in quality management, data strategy, monitoring innovation, and the future of risk-based oversight.