Discovery has accelerated.
Submission has not.
Koneksa has the fix.
Introducing Lodestar,
the first intelligent submission software.
From raw EDC data to FDA + EMA submission,
under one auditable workflow.
From SAP interpretation through CDISC mapping, code generation, QC, and eCTD assembly, every step of the submission pipeline in one connected, audit-trailed workflow. Each AI-generated output is reviewed and approved by a named human, cryptographically signed under 21 CFR Part 11, and traceable to source.
Built by experienced statisticians, data managers, and regulatory leaders. Internally validated against a completed Koneksa-sponsored study. Now in early access with select sponsor and CRO partners.
The Submission Stack was Never Designed to Move this Fast. Until Now.
Lodestar replaces a fragmented stack of tools, multiple teams, and months of manual stitching.
Existing tools and services support pieces of this process. Koneksa is the first to integrate the full path into a single workflow with built-in oversight, traceability, and alignment to global regulatory expectations.
Where other tools operate vs. where
Lodestar covers the full path
EDC Ingest
SDTM Mapping
ADaM Generation
Protocol + SAP Overread
TLG Shells + Render
QC + Sign-off
SDRG / ADRG
eCTD Assembly
BIMO Package
eTMF Push
Submission
Automation Tools
TLF + Packaging
Tools
MetaData
Tools
Validation
Tools
This is not a faster version of the same process.
It is a different operating model.
Biometrics teams spend ~80% of their time on mechanical derivations.
That is the time Koneksa eliminates.
The remaining 20%, clinical judgement, protocol-specific logic, regulatory strategy, stays exactly where it belongs: with the statistician.
What This Changes in Practice
AI-assisted,
human-approved, by design
Every AI-generated output requires explicit approval by a named reviewer before entering the submission pipeline. Confidence thresholds and audit controls are enforced within the system. Not automation replacing expertise, expertise operating at scale.
Regulatory
artifacts auto-assembled
Submission-ready artifacts, including SDRG, ADRG, Define.xml, BIMO inspection packages, and eCTD Module 5.3, are generated directly from system metadata and staged for transmission to FDA and EMA submission systems.
Built for where regulation is
going
Aligned with the FDA’s January 2025 guidance on AI for regulatory decision-making, including model risk classification, human review, lifecycle monitoring, and a per-component AI Credibility Assessment Report mapped to the seven-step framework.
SAP and
Protocol read in minutes, not days
Statistical Analysis Plans and Protocols are parsed to extract endpoints, populations, methods, and assessments. Outputs are structured and traceable back to source text.
Validation throughout, not
end-of-study
Conformance checks, mapping validation, and double programming run continuously as work progresses. Issues are identified earlier when they are easier to resolve.
Early Validation.
Measurable Impact.
Data from a completed Koneksa-sponsored study was run end-to-end through the pipeline and compared against a traditional submission workflow.
What We Saw
80% reduction
in hours spent programming
65% lower
biometrics
costs
16X faster
QC cycles
100%
Audit-ready
outputs
Configured out of the box for eight therapeutic areas and five different EDC integrations, with ongoing pilot programs expanding coverage.
Real-World Validation
Outputs were consistent with the traditional workflow across CDISC datasets and analysis tables in a completed Koneksa-sponsored study.
Additional sponsor pilot programs are underway to extend validation across studies and therapeutic areas.
Download our fact sheet to learn how we stack up against the traditional process.
Built for Teams Who Own Submission
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Biopharma sponsors seeking earlier insight and a faster path to submission
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Biometrics and data science teams responsible for analysis integrity, audit traceability, and regulatory deliverables
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CRO teams scaling delivery without increasing headcount
Built by Teams Who Do This Work
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Developed and operated by Koneksa’s tenured team
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Supporting FDA + EMA submissions across 20+ therapeutic areas, with deep biometrics and regulatory expertise
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Working together for >10 years across studies, sponsors, and submission types
Start Operating in Submission-Ready Mode
Lodestar is currently available through early access and design partner engagement, with a limited number of sponsors and CRO partners applying the pipeline in active studies to refine its role in real-world submission workflows.