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Session 4: Strategies for Managing Complex Digital Health Data Sets for Successful Regulatory Submissions
Session Chair(s)
Rachel Chasse, MS
Digital Operations Lead
AbbVie, United States
Clinical research has entered the world of digital health technologies (DHT), but what happens when large datasets are full of holes? In this session, leaders will discuss best practices on how to strategically manage large data sets: from how to plan for variability to accounting for adherence challenges and everything in between. In this session, we will discuss how data management strategies addressing these topics can support successful regulatory submissions.
Learning Objective : At the conclusion of this session, participants should be able to:
- Deploy proactive approaches to collecting and ingesting large data sets
- Discuss realistic expectations for analyzing data before collecting begins
- Identify data management strategies for managing voluminous continuous data
Speaker(s)
Speakers
Aman Thukral, MPharm, MS
AbbVie, Inc., United States
Head of Digital Operations & Clinical Systems Data and Statistical Science (DSS)
Managing Complex Digital Health Data Sets for Successful Regulatory Submissions
Jennifer Goldsack, MA, MBA, MS
Digital Medicine Society (DiMe), United States
Chief Executive Officer
Considerations to Address Missing Data When Deriving Clinical Trial Endpoints from Digital Health Technologies
Wenyi Lin, PhD, MS
Pfizer, United States
Manager, Biostatistics, Digital Sciences and Translational Imaging (DSTI)