Bridging the Gap: A Validated Pipeline for Transforming High-Frequency Sensor Data to SDTM

About this session

Part of Session 4, Track C: RWD/DCT (Chair: Donna Sattler, Eli Lilly).

As wearable sensors and digital health technologies (DHTs) become ubiquitous in clinical trials, the industry faces a significant challenge: transforming massive volumes of raw sub-second data into submission-ready SDTM datasets without compromising data integrity or traceability.
This presentation explores a robust data flow architecture utilizing the Digital Health Measurement Collaborative Community (DiMe) V3 framework (Verification, Analytical Validation, and Clinical Validation). We detail a specialized pipeline for transitioning from raw sensor output to structured clinical domains. Attendees will understand how to build a scalable, compliant bridge between raw sensor outputs and CDISC standards, ensuring that digital endpoints are as rigorous and transparent as traditional clinical measures.

Speakers

• 

  Aman Thukral

  Director & Head, Clinical Systems & Digital Operations · Abbvie

  Speaker

• 

  Sanjay Bhardwaj

  Executive Director, Head of Clinical Data Technologies · Abbvie

  Speaker

• DS

  Donna Sattler

  Eli Lilly

  Chair