Videos
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June 6, 2017
Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium
This webinar provides a recommended framework for the selection and evaluation of wearable devices and their measurements for use in regulatory trials to support labeling claims. The webinar will also address the essential properties of fit-for-purpose wearables and the activities required to establish clinical endpoints derived from data collected with wearable devices. Presenters: Bill Byrom,... -
May 22, 2017
miR-122 An Exploratory Biomarker of Liver Injury: An Industry Perspective on the State of the Science and Experiences Pre-Clinically and Clinically
The Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) hosted a webinar focused on providing an industry perspective on the state of the science and preclinical and clinical experiences with mi-R122. This webinar was hosted by PSTC’s Hepatoxicity Working Group. The first presentation discussed the current state of miR-122 as a safety biomarker of liver... -
February 28, 2017
Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically
This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments. Presenter: Paul O’Donohoe, MS (CRF Health) -
February 28, 2017
Considerations for Requiring Subjects to Respond to PRO Instruments Collected Electronically
This webinar provides an overview of specific considerations related to allowing subjects to opt out of responding to individual items when PRO data collection is electronic as well as the relevance to other types of electronic clinical outcome assessments. Presenters: Paul O’Donohoe, MS (CRF Health) and Sonya Eremenco, MA (C-Path) PDF version -
February 24, 2017
Biomarker Qualification: Collaboration, Strategy, and Implementation
Biomarker Qualification: Collaboration, Strategy, and Implementation Webinar February 24th, 2017 Presenter: John Michael Sauer, PhD