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Digital Technology in Clinical Trials
Session 1 Track B: Data Principles & Solution Patterns to Unlock our Data Wealth
Session Chair(s)
Keith Wenzel
- Senior Director, Scientific Data Organization
- Parexel International, United States
Clinical Trials generate enormous tombs of data. EDC generates many gigabytes of data for each trial. Verbose auditing increase datasets by 10x. Wearables and other sensors increase datasets (again) by 10x to 100x. RWE datasets are only bounded by the potential candidate pool of all people with their health records digitized. How are we to deal with our data explosion? From the fable “The Miser and his Gold”, how do we ensure our data is “a wealth we use” as wealth not used is the same as wealth that does not exist. This session will discuss maintaining data principles, embracing proven big data patterns, and leveraging the benefits of cloudification with cost vigilance to achieve the data agility our clinical trials demand.
Learning Objective : - Propose a set of data principles to guide big data strategy
- Describe big data solution patterns
- Defend that successful DataOPS requires cloudification with cost vigilance
Speaker(s)
Data Principles & Solution Patterns to unlock our Data Wealth
Steven Chartier, MS
- Sr. Director of Engineering
- Calyx, United States

Speaker
Patrick Nadolny, MS
- Global Head, Clinical Data Management
- Sanofi, France
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Registration Questions?
Preconference Short Courses
Short Course 1: Approaches for Developing Novel Digital Endpoints for Medical Product Development
Additional Information
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Digital Technology in Clinical Trials Resource Kit