Tag: remote monitoring

Clinical Research: Phase 1 - Phase 4

TrialSite News: Going Virtual: How to Implement mHealth and Remote Monitoring in Your Clinical Trials

In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise...

COVID-19

Statistical Considerations for FDA COVID-19 Guidance

In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlighting specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention to some general actions required to ensure the operational integrity and scientific...