News & Events
January 30, 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)...
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)...
May 18, 2016
PRO Consortium Webinar: Methods for Determining Clinically Meaningful ChangeThis webinar explores methodological approaches for determining whether changes observed in patient-reported outcome measures and other clinical outcome assessments are clinically meaningful. Moderator: Stacie Hudgens, MA (Clinical Outcome Solutions) Presenters: Joseph C. Cappelleri, PhD (Pfizer Inc.), Cheryl Coon, PhD (Outcometrix) and Kathy Wyrwich, PhD (Evidera)...
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)...
September 2, 2015
Evidentiary Considerations for Integration of Biomarkers in Drug Development SymposiumEvidentiary Considerations for Integration of Biomarkers in Drug Development Symposium On August 21st, the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), the U.S Food and Drug Administration (FDA), and the Critical Path Institute co-sponsored a symposium titled “Evidentiary Considerations for Integration of Biomarkers in Drug Development” at the University of......