Conference: CDISC US 2025
Date: October 13 - 14, 2025
Location: Nashville, TN
Hear key learning objectives and insights from our CDISC experts
Authors: Jeffrey Abolafia, Director of Product Innovation, Certara; Sarah Ferko, Senior Managing Consultant, IBM Consulting; Ingeborg Holt, Data Integration & Analytics Expert, Orizaba Solutions
There is a rapid increase in the use of RWD to support marketing applications. However, submitting RWD may pose numerous challenges for regulatory reviewers in their analysis of the data.
In our five previous papers, we outline these challenges and present several high-level solutions. This current paper builds on our previous work by taking a deep dive into CDISC SDTM example data and highlighting updates needed to the SDTM to better accommodate RWD.
Specifically, we examine the gaps in the Subject Visits domain for its use in regulatory review. Considering how other models such as HL7 FHIR, OMOP, and PCORnet handle certain elements, we propose updated domains and data elements to represent patient encounters that are a key component of RWD.
These ideas are intended to help sponsors submit RWD and to continue the conversation with SDOs such as CDISC around the updates needed for more efficient regulatory review.
Watch this short video and see how to supercharge your data pipeline
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