News & Events
June 6, 2017
Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO ConsortiumThis 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,......
February 28, 2017
Considerations for Requiring Subjects to Respond to PRO Instruments Collected ElectronicallyThis 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...
January 31, 2017
Bring Your Own Device (BYOD)This webinar provides an overview of scientific, logistical, and regulatory considerations when using a BYOD approach to collect patient-reported outcome data in clinical trials. Presenters: Jennifer Crager (YPrime) and Paul O’Donohoe, MS (CRF Health) PDF version...
October 27, 2016
Ensuring Equivalence of Electronic and Paper Administration of Patient-Reported Outcome MeasuresThis webinar provides an overview of scientific and regulatory considerations when migrating paper-based patient-reported outcome (PRO) measures to electronic modes of data collection. Presenters: Paul O’Donohoe, MS (CRF Health) and Willie Muehlhausen, DVM (ICON) PDF version...
January 7, 2016
Best Practices for ePRO Implementation in Clinical TrialsThis webinar provides an overview of considerations in selecting the optimal ePRO modes, review best practices related to the deployment of ePRO systems, and discuss key items for ePRO deployment in clinical trials. Presenters: Serge Bodart, MS (Biomedical Systems) and Elisa Holzbaur, BS, PMP (Almac) PDF version ...