Medical and Regulatory Affairs
Protected: PREMIER VOICES #15: Understanding EU Regulatory Requirements in Gene Therapy Development
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Tag: mobile health
Data Management & Biostatistics
Explainer Video: ePremier Hybrid Case Study
Today’s technology enables us to seamlessly integrate data for every stage of a clinical trial, from lab results to mobile health apps, patient-reported data, and much more. These new sources of data allow us to better interpret, predict, and quickly turn around a study that may be stalled due to lagging enrollment, regulatory challenges, or...
Consulting
Entering a New Clinical Phase of Non-Traditional Data Sources
This is part two of a two-part series, you can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy. The rise of real-world data and real-world evidence Non-traditional data points, in particular real-world data (RWD)...
Clinical Research: Phase 1 - Phase 4
Premier Presentations from WODC
Watch Premier Research’s presentations from World Orphan Drug Congress 2020 below. Note: You must be logged into your WODC Swapcard account to view presentations Rare Disease Recruitment: Addressing Enrollment Hurdles and Differentiating Your Clinical Trial in an Increasingly Competitive Research Environment Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease & Pediatrics, shares tips for overcoming...
Clinical Research: Phase 1 - Phase 4
Premier Research Launches Electronic Collection of Clinical Trial Patient Data
DURHAM, N.C., MARCH 24, 2017 — Premier Research is launching a smartphone-based patient reported outcome system to replace the paper diaries used in many clinical trials. Premier Mobile ePRO will give sponsors and researchers more accurate and timely patient reported data while reducing the burden on trial participants. “Any study is only as good as...
Clinical Research: Phase 1 - Phase 4
Mobile clinical research. There’s an app for that.
Visit the iTunes App Store or Google Play and you will find the smartphone app PoopMD+: A New Parent’s Guide to Baby Poop and Pediatric Liver Disease Study from Johns Hopkins. PoopMD+ is an imaging and clinical survey-based app developed to help screen for a rare but life-threatening liver disorder in babies and collect feedback...