AI-Ready FDA Submissions: CDISC, Validation, and Machine-Readable Data

AI Builders Global Conference 2026

Date to be announced · Time to be announced

AI builders working in regulated healthcare need more than accurate models. They need reliable, traceable, and machine-readable data foundations. This session explains how statistical programmers prepare FDA review-ready clinical data packages across NDA, BLA, IND, sNDA, and rolling-review pathways, and how these practices can support responsible AI adoption in regulatory workflows. Attendees will follow the submission lifecycle from Pre-IND activities through NDA or BLA filing and Complete Response Letter support. The session covers programmer responsibilities within eCTD Modules 2.7 and 5, CDISC implementation using SDTM and ADaM, Define-XML 2.1, and commonly used analysis datasets such as ADSL, ADAE, ADLB, ADTTE, and ADRS or ADTR. The presentation also examines validation and quality controls involving SDRG, ADRG, Pinnacle 21, Analysis Results Metadata, and dual-programmer review. It connects these established practices with emerging AI-ready submission capabilities, including Dataset-JSON, growing use of R alongside SAS, and machine-readable metadata. Participants will leave with a practical framework for building compliant, validated, and structured clinical data foundations that can support automation and future AI-enabled regulatory processes.

Session status: scheduled

Track: No Preference

Level: Intermediate

Official session / agenda

Saving a session is not registration. Check the official agenda for availability, eligibility and any additional fees.

Speakers and their event affiliations

Parent event

Virtual · Online event

This describes the parent event. Confirm the session’s attendance requirements with the organizer.

Companies participating in the parent event

These are event-level relationships, not confirmed sponsorship of this session.

Showing 24 of 209 company relationships. View all on the event page.