Medical and Regulatory Affairs
Protected: PREMIER VOICES #15: Understanding EU Regulatory Requirements in Gene Therapy Development
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Tag: virtual trials
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)...