Making data surveillance a reality with Tanya du Plessis

In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Tanya Du Plessis, Chief Data Strategist and Solutions Officer at Bioforum. Together, they unpack what data surveillance really means and how to make it a practical reality in today’s clinical trials.

With over two decades of experience in clinical data management, Tanya shares how the evolving regulatory landscape – including ICH E8 and ICH E6(R3) –  is pushing sponsors to adopt a more holistic, risk-based view of data. Rather than reacting to problems at the end of a study, she explains how data surveillance empowers teams to identify risks earlier, address root causes, and protect trial integrity.

Sylvain and Tanya discuss why regulators intentionally avoid a rigid definition of data surveillance, how cross-functional collaboration between statisticians, medics, and data managers is key, and why proactive strategies ultimately save both time and cost. 

Tune in to explore how data surveillance is reshaping the role of data managers, the culture of oversight, and the future of trial success.