Lodestar™ vs. the Traditional Submission Stack: A Side-by-Side Comparison

The Submission Stack Was Never Designed to Move This Fast. Until Now.

The clinical submission workflow hasn’t kept pace with the tools around it. Despite advances in automation and AI, submissions still run on fragmented workflows, repeated handoffs, and manual reconciliation across programming, QC, and regulatory operations. Every export, rename, and re-validation adds days and risk.

Lodestar™ replaces that stack. It’s the first intelligent submission software connecting biometrics, QC, regulatory artifacts, and eCTD assembly into one AI-assisted, auditable workflow with human oversight, continuous validation, and end-to-end traceability.

A Connected Clinical Submission Workflow, Step by Step

The fact sheet walks through all ten stages of the pipeline side by side, traditional stack versus Lodestar™. A sample of what changes:

• EDC ingest: manual exports and reconciliation checks become direct ingestion with chain-of-custody validation. Days to minutes.
• SDTM mapping: weeks of manual domain mapping become AI-assisted mapping generation with human approval. Six-plus weeks to days.
• TLG shells and render: sequential rendering and reruns become parallelized execution from SAP-aligned shells. Weeks to days.
• BIMO package: cross-functional document scrambles become centralized inspection package generation from one source of truth. Hours to minutes.

The same transformation applies across ADaM generation, SAP overread, QC and signoff, SDRG/ADRG authoring, eCTD assembly, and eTMF push.

The Cumulative Impact

Fewer manual handoffs, faster submission readiness, and scalable delivery without linear headcount growth. Instead of adding programmers to move faster, the clinical submission workflow itself gets faster, with integrated audit-ready approvals and traceability at every step. See it for yourself in this side-by-side comparison of Lodestar™ versus the traditional submission stack.