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

Thu, Aug 13

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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.


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