CDISC US 2025

Session 6: Track B – New Data Sources (RWD)

Presenter: Ingeborg Holt, Data Integration & Analytics Expert, Orizaba Solutions

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.

Session 6: Track B – New Data Sources (RWD)

Author: Julie Ann Hood, Principle CDISC Consultant, Certara

Behind every high-quality, CDISC-compliant SDTM dataset lies a team- not of ordinary professionals, but of data-driven heroes, each with their own unique skillsets and battle-tested expertise.

In today’s clinical trials, creating and validating submission-ready datasets is rarely a solo mission. It’s a full-scale, multi-role operation that calls upon the powers of Data Managers, Standards Managers, Clinical Programmers, and Biostatisticians, each bringing something special to the fight for clean, conformant data.

Our heroes may come from different domains, but they share a common trait: a working knowledge of CDISC standards. Whether it’s SDTM variables on an aCRF, CDASH-structured EDC systems, or routine exposure to standardized specs, each role is already familiar with the tools of the trade. This foundational knowledge becomes their secret weapon, breaking down long-standing silos and enabling smarter, more collaborative workflows than ever before.

In a world of evolving standards, AI-assisted processes, and increasing expectations for speed and accuracy, the path to submission success isn’t always linear. There’s no single “right way” to create SDTM datasets, but there are more efficient ways.

Understanding the strengths of each role opens up opportunities to rethink traditional processes, distribute tasks more effectively, and innovate with workflows that leverage each team member’s unique expertise.

This poster will present our SDTM Squad in full force, outlining the signature skills and superpowers each role brings to the clinical trial data lifecycle, alongside the emerging contributions of AI. From the Data Manager’s deep study knowledge to the Biostatistician’s analytical foresight, and the Standards Manager’s metadata mastery to the Programmer’s precision code, we’ll explore how these abilities combine to form faster, more efficient processes for SDTM dataset creation and validation.

By highlighting the strengths of this dynamic team, we’ll demonstrate that with the right strategy and collaboration, regulatory compliance can be both faster and more heroic.