Real-world data (RWD) is increasingly used to support clinical development, safety evaluation and regulatory evidence generation. However, converting electronic health records, claims and registry data into Clinical Data Interchange Standards Consortium (CDISC)-compliant datasets requires more than simple data mapping. Patient histories must be reconstructed, coding systems aligned and clinical context preserved to ensure traceable, review-ready evidence.
This webinar will explore a practical framework for transforming RWD into submission-ready CDISC datasets through data fitness assessment, source harmonization, controlled mapping, SDTM implementation, validation and end-to-end traceability. The featured speakers will discuss the importance of maintaining data quality, consistency and reproducibility throughout the transformation process to support regulatory review.
The session will also explore how AI can accelerate mapping, terminology reconciliation, specification development and quality control while maintaining regulatory compliance through human oversight, provenance tracking and conformance testing. Attendees will gain insights into how these approaches can reduce manual effort, improve workflow consistency and support scalable RWD evidence generation without compromising data integrity.
Register for this webinar to learn how AI-assisted RWD transformation can improve data traceability, streamline CDISC mapping and strengthen regulatory readiness.
Who Should Attend
This webinar will appeal to professionals involved in real-world evidence generation, clinical data management, regulatory submissions and biometrics, including:
Head of Real-World Evidence (RWE) or Observational Research
Head of Epidemiology
Evidence Generation or Integrated Evidence leaders
Biometrics or Statistical Programming leaders
Medical Evidence leaders
Regulatory Affairs/Science or Data Standards leaders
Oncology Clinical Development leaders
Register free on Xtalks: https://xtalks.com/webinars/use-ai-to-accelerate-rwd-transformation-for-regulatory-submissions/
