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Meet Lodestar™: your northstar for regulatory submissions
Meet Lodestar™: your northstar for regulatory submissions

Tue, Jul 21

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Webinar

Meet Lodestar™: your northstar for regulatory submissions

Introducing he first AI-assisted submission software that takes you from raw EDC data to FDA + EMA-ready, under one auditable workflow.

Time & Location

Jul 21, 2026, 11:00 AM – 12:00 PM EDT

Webinar

About the event


Discovery has accelerated.

Submission has not. That changes now. 

From database lock to eCTD assembly, the traditional path is a fragmented maze of tools, handoffs, and manual stitching, where issues surface late in the process, QC cycles drag on, and biometrics teams spend 80% of their time on mechanical work that should take minutes, not months. Lodestar™, the first-of-its-kind intelligent submission software, offers a different operating model. 


Register for this webinar to see: 

  • How Lodestar™ covers the full submission path, from CDISC mapping and ADaM generation through QC, regulatory artifact assembly, and eCTD, in one connected, audit-trailed workflow 

  • What "AI-assisted, human-approved by design" actually looks like in practice: every AI-generated output reviewed by a named human, cryptographically signed under 21 CFR Part 11, and traceable to source 


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