LODESTAR WEBINAR
AUGUST 13 – 11AM EDT
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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. Lodestar™ was validated using data from the completed LEARNS clinical study, Koneksa’s observational Parkinson’s disease program evaluating wearable, mobile, and digital biomarker endpoints. Now in early access with select sponsor and CRO partners.
Request Early Access →Register for Webinar →

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

Lodestar vs. other data 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.

Deep regulatory-ready experience

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.

Digital Endpoints

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 the completed LEARNS clinical study was run end-to-end through he pipeline and compared against a traditional submission workflow.

What We Saw

80% reduction

in hours spent programming
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65% lower

biometrics
costs

16X faster

QC cycles
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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.

Download the Fact Sheet

Built for Teams Who Own Submission

  • Biopharma sponsors seeking earlier insight and a faster path to submission
  • Biometrics and data science teams responsible for analysis integrity, audit traceability, and regulatory deliverables
  • CRO teams scaling delivery without increasing headcount

Built by Teams Who
Do This Work

  • Developed and operated by Koneksa’s tenured team
  • Supporting FDA + EMA submissions across 20+ therapeutic areas, with deep biometrics and regulatory expertise
  • Working together for >10 years across studies, sponsors, and submission types

Start Operating in Submission-Ready Mode

Koneksa Lodestar Intelligent Submission Software

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.

Complete form to request early access.