Lodestar™: Your North Star for Regulatory Submissions

Explore Lodestar™: Your North Star for Regulatory Submissions

Most biometrics teams spend the majority of their time on mechanical work scattered across disconnected tools with no single source of truth. Lodestar™ changes that. It’s the first intelligent regulatory submission software to connect every step of the pipeline, from EDC ingest through eTMF push, in one continuously validated, AI-assisted workflow built for 21 CFR Part 11 compliance.

The results, validated on a completed clinical study:

• 80% less programming time
• 16x faster QC cycles
• 65% lower biometrics costs
• 100% audit-ready outputs

Validated using data from the completed LEARNS clinical study; outputs compared against a traditional submission workflow.

Regulatory Submission Software That Covers Every Step

Point solutions handle fragments of the submission pipeline: one tool for SDTM mapping, another for TLG rendering, another for eCTD assembly, with manual handoffs and revalidation at every seam. Lodestar™ runs the entire sequence in one place: EDC ingest, SDTM mapping, ADaM generation, protocol and SAP overread, TLG shells and rendering, QC and sign-off, SDRG and ADRG authoring, eCTD assembly, BIMO packaging, and eTMF push. One environment, one audit trail, no handoffs.

Koneksa built Lodestar™ to power its own biometric operations. Every database build and biometrics program Koneksa delivers runs on it.

Reach FDA and EMA Submission Faster

Whether through Koneksa’s services or licensed for your own team, Lodestar™ gets you to filing with more speed and more confidence. Download the fact sheet to learn how.