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How to Trust Data from Wearable Devices Used in Clinical Trials
Session Chair(s)
Hitoshi Matsui
Advisor
CAC Corporation, Japan
It appears that wearable medical devices do not pay as much attention to data quality and integrity as our GxP computerized systems that store the data. This session will identify wearable devices and discuss how to qualify data so that they meet good practice guidelines.
Learning Objective : Describe current and future uses of wearable devices in clinical trials; Discuss how applications using wearable devices are qualified; Identify how to validate applications on wearable devices; Define how to verify data from wearable devices.
Speaker(s)
Expectations and Concerns for Using Wearable Devices in Clinical Trials From a Sponsor’s Point of View
Yumi Wakabayashi, MBA
Janssen Pharmaceutical K.K., Japan
Manager, Global Regulatory Policy & Intelligence, Asia Pacific
The Impact of Wearables On Your Organization
Willie Muehlhausen, DVM
SAFIRA Clinical Research, Ireland
Co-Founder
Wearable Devices in Clinical Trials: How To Adapt To A New Paradigm
Hitoshi Matsui
CAC Corporation, Japan
Advisor
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