Dudley Tabakin
Founder & CEO, VivoSense
Key Points
- Start with the measure, not the device
- Data governance matters as much as the sensor itself
- Meaningful endpoints come from patient input
- Early phase studies are the best place to begin
- Wearable data creates huge volumes — quality beats quantity
- Combining sensor data with PROs, eCOA, and labs for stronger evidence
Tom Lazenby interviews Dudley Tabakin, founder and CEO of VivoSense, about using wearable sensors in clinical trial endpoints — and why the device itself is the last thing you should be thinking about.
They discuss how to choose the measure that matters to patients first, then work backward to the sensor, the algorithm, and the evidence a regulator will actually accept. Dudley explains the gap between a consumer wearable and a clinical-grade endpoint, and why sponsors who pick the device first usually end up with data nobody can use.
The conversation covers where sensors earn their keep — early phase studies, and rare disease in particular, where an objective continuous measure can capture what an episodic clinic visit never will. Dudley also makes the case that clinical validation, not the technology, is the real regulatory hurdle, and shows what happens to statistical power when a large share of the collected data goes missing.
Drawing on twenty years of solving hard measurement problems, Dudley brings a practical view of what it takes to turn high-volume sensor data into audit-ready results, and why wearable data works best paired with PROs, eCOA, and labs rather than standing alone.
Chapters
About the Guest
Dudley Tabakin
Founder & CEO, VivoSense
Dudley Tabakin is founder and CEO of VivoSense and a clinical research operations leader with over 20 years of expertise in Life Sciences. An operations generalist known for solving hard measurement problems, he leads a complete wearable-sensor CRO that turns high-volume, complex sensor data into structured, audit-ready results.
His expertise spans wearable sensor technology, clinical research analysis, motion capture, and biomechanical modelling. Dudley argues that a digital endpoint starts with the measure that matters to patients, not the device on their wrist — and that the hard part is never the hardware, it is the clinical validation that makes regulators accept what the sensor produces.
Want to discuss vendor oversight?
Book a consultation with Tom Lazenby to explore how Mayet can support your clinical QA needs.