Neurological Drug Safety

Continuous temperature monitoring for drug safety


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Study Scope and Protocol

One of the primary indicators of patient safety and efficacy in this trial is changes in body temperature over extended periods.

This study leveraged Vivalink’s Biometric Data Platform the medical grade wearable temperature monitor to analyze patient temperature in ambulatory and at-home settings over a 3 week period.


Key Components

  • Biometrics Data Platform
  • Wearable Temperature Monitor
  • Custom Mobile Patient App
  • Temperature Trend Analysis
  • Clinical Systems Integration

Data Captured

  • Axillary Temperature
Requirements/Challenges Solution
Ambulatory impacts to temperature variations Trend analysis to flag artificial temperature changes
Extended monitoring period 21 day rechargeable temperature sensors
Network disruptions in ambulatory settings Sensors with onboard memory and automated network data synchronization
Data integration with clinical systems M2M web services API integration


"The integration of Vivalink's innovative RPM technology with Bioclinica's global clinical trial infrastructure will open new paradigms for trial data collection and analysis."

- Thomas Fuerst, PhD, Chief Science Officer of BioClinica