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May 18, 2016
PRO Consortium Webinar: Methods for Determining Clinically Meaningful Change
This 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 Trials
This 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 ... -
September 2, 2015
Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposium
Evidentiary 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...... - August 21, 2015
- July 2, 2015