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WEBINAR EVENT
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Meet Lodestar™: your north star for regulatory submissions

The first AI-assisted submission software that takes you from raw EDC data to FDA + EMA-ready, under one auditable workflow.
TUESDAY  |  JULY 21, 2026  |  8AM PDT / 11AM EDT

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. ​

In this webinar, you will explore:

How Lodestar™ covers the full submission path in one connected, audit-trailed workflow

What "AI-assisted, human-approved by design" actually looks like in practice

How clinical, data, biometrics, and regulatory teams can align faster under submission pressure, with validation running continuously, not just at the end 

Where AI handles the mechanical derivations, and where scientific judgment, protocol logic, and regulatory strategy stay exactly where they belong: with your team 

The real-world impact: 80% reduction in programming hours, 65% lower biometrics costs, and QC cycles that run 16X faster 

The future of submission isn't a better spreadsheet or a faster version of the same process. It's a connected workflow where every step is accountable, every output is audit-ready, and your experts spend their time on the work that actually requires them. 
Come See what that looks like.
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Can't Attend the Webinar?

Stay tuned for the recording or contact us today to request early access to Lodestar™.
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