News & Events
May 10, 2018
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium (May 10, 2018)This webinar provides a recommended framework for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials. The goal of the webinar is to promote consistent and sufficient training prior to initiating data collection. Presenters: Jenny J. Ly, PhD (ERT) and Serge Bodart, MSc (Bracket) PDF version...
November 22, 2017
HD-RSC Kick-off: Charles Sabine PresentationThe kickoff meeting for a new dedicated worldwide consortium focused on Huntington’s disease took place on November 6 and 7 in Silver Spring, Maryland. The goal of this meeting was to gather relevant stakeholders to align on the purpose and potential opportunities which could benefit from precompetitive collaboration for accelerating HD therapeutics. · The Kickoff......
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,......
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 ClinicallyThe 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 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. Presenter: Paul O’Donohoe, MS (CRF Health)...