Controlling Your Data from Collection to Submission

Speaker(s): Somya Agarwal, Nick Brown, & Erin Erginer (CERTARA)

Data is the foundation of every successful regulatory submission. In this session, we'll demonstrate how standardizing data at the point of collection leads to efficiency gains in validation, study report authoring, and regulatory submission. You'll learn how the right software solutions for standards governance, dataset validation, GenAI-powered writing, and eCTD assembly can work in concert to ensure the integrity and flow of your data from "first patient first visit" to regulatory transfer. Your operations can't afford disjointed workflows. Neither can patients in need.

Join the Certara and DIA to explore a practical path from data capture to submission readiness.

Topics:

• Ensuring submission-ready, validated datasets
• Accelerating CSR development with structured data
• Streamlining eCTD assembly and regulatory delivery