top of page


Thu, Aug 13
|Webinar
Meet Lodestar™: your northstar for regulatory submissions
For the first time, the entire submission process is defined, connected, and run inside one environment. Lodestar™ is intelligent submission software that takes you from raw EDC data to FDA + EMA-ready, under one AI-assisted, auditable workflow.
Time & Location
Aug 13, 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.
For the first time, the process of the submission path has been defined and unified into 10 steps, run inside one AI-assisted, audit-trailed environment changing the game for sponsors and CROs when it comes to submission. No more bouncing between systems, no more xyz. Lodestar™, is not a faster version of the old process. It’s one that didn’t exist before.
Three perspectives, one conversation.
bottom of page