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The End-to-End
Clinical Data Pipeline Engine.

We convert clinical study documents and trial data into submission-ready statistical outputs. From Protocol to SDTM, ADaM, and TLFs—automatically.

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BioParity Engine — v1.0
user@bioparity:~$ ./run_pipeline --study=DEV-2026 --input=./docs
Reading Protocol_v3.pdf... Done
Reading SAP_Final.pdf... Done
Ingesting Raw EDC Data (CSV)... Done

> AI: Generating Mapping Specifications...

Mapping 'DOB' -> 'BRTHDTC' (ISO8601)

Annotating eCRF domains (DM, AE, VS, LB)

> AI: Producing SDTM Datasets...

Constructed dm.xpt, ae.xpt, lb.xpt, vs.xpt

> AI: Deriving Analysis Datasets (ADaM)...

Derived ADSL (Safety Flag calculated from Protocol rules)

Derived ADTTE (Time-to-event logic applied)

✔ Pipeline Complete. Outputs ready in /submission_package

The "Manual Translation" Bottleneck

Today, biostatistics and programming teams manually translate Protocols, CRFs, and SAPs into datasets and reports.

This process relies on repetitive, spec-driven programming and manual QC. It is slow, prone to inconsistency, and carries high submission risk.

"We spend 60% of our time writing specs and mapping variables, and only 40% on actual analysis."

The BioParity Solution

Our product acts as an end-to-end clinical data pipeline engine. Instead of writing code from scratch, teams receive AI-generated specs, datasets, and outputs they can simply review and finalize.

  • ✓
    Reduces programming time by automating mapping logic.
  • ✓
    Improves consistency via standardized SDTM/ADaM generation.
  • ✓
    Lowers submission risk with built-in traceability & QC.

Submission-Ready Outputs

BioParity reads your study documents and generates the full package.

Mapping Specs

Auto-generates mapping specifications from Protocol/CRF to SDTM, eliminating manual Excel work.

SDTM & ADaM

Produces standardized datasets and derivation logic directly from the Analysis Plan.

Annotated eCRF

Automatically annotates Case Report Forms with SDTM variables for submission.

TLFs & Reports

Generates Tables, Listings, and Figures populated with data, ready for the CSR.

From upload → submission package

How it Works

BioParity turns study documents + raw data into SDTM/ADaM and TLFs with a full audit trail. Your team stays in control: review every mapping, derivation, and output with traceable evidence.

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1

Ingest Protocol, SAP, CRF, and Raw Data

Upload your study documents and EDC exports. BioParity normalizes formats and identifies study metadata, endpoints, visit schedules, and domain coverage.

Protocol / SAP / aCRF
Raw EDC exports (CSV)
2

Generate Specs and Derivation Logic

The engine drafts SDTM mapping specs and ADaM derivations with field-level evidence. Every rule is linked back to the source section in the Protocol/SAP.

Mapping specs (Protocol → SDTM)
Derivation rules (SAP → ADaM)
3

Produce SDTM, ADaM, and TLFs

BioParity executes transformations to produce standardized datasets and draft outputs (tables/listings/figures). Outputs come packaged with validation artifacts and traceability metadata.

SDTM (DM, AE, LB, VS…)
ADaM + draft TLFs
4

Review, QC, and Export Submission Package

Review diffs, approve mappings, and export a clean submission-ready package with audit trails. Built-in checks highlight inconsistencies and missing evidence before they become submission risk.

Evidence-linked rules Cross-document QC Traceability report
What you get
/submission_package
  • Specs (mapping + derivations) with source references
  • SDTM/ADaM datasets (standardized + validated)
  • TLFs draft outputs populated from analysis datasets
  • QC report with findings, diffs, and traceability
example
✔ mapping_specs.xlsx
✔ sdtm/ (dm.xpt, ae.xpt, lb.xpt...)
✔ adam/ (adsl.xpt, adtte.xpt...)
✔ tlf/ (tables, listings, figures)
✔ qc/findings.json
✔ traceability_report.pdf
Designed for reviewability: every output can be traced back to the exact Protocol/SAP source text that generated it.
Governance built-in
  • Evidence-gated rules to reduce hallucinations
  • Review and approval workflow for every change
  • Exportable audit trail for sponsors and regulators

Product Demo

Watch a quick walkthrough of BioParity in action.

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Watch on YouTube

Stop building the pipeline from scratch.

Join the waitlist to automate your clinical data lifecycle.

Letter of Intent + Feedback (Google Form)

Prefer a lightweight LOI + requirements capture? Use the form above.

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