AI-Powered Clinical Development. Accelerated Submissions.

Intelligent Clinical Development. Faster Submissions.

eClinTrial AI helps sponsors turn clinical trial data into submission-ready deliverables faster — improving efficiency, reducing cost and shortening the time to regulatory submission.

Explore SDTM Studio Talk to us →
  • CDISC SDTM
  • Controlled Terminology
  • Define-XML 2.1
  • CDISC CORE
SDTM Studio: AI-drafted domain workflows with dry-run results
Fasterdata processing and analysis
Efficientexperts focus on review, not repetition
Lower costless manual programming per study
Soonerregulatory submission
Our Mission

Use AI to take months out of the clinical data timeline.

Between the last patient visit and a regulatory submission sit months of data standardization, programming, validation and documentation. Much of that work is repetitive. We build AI-native software that does the first draft, so sponsor teams can concentrate on the decisions that need their expertise.

Accelerate data processing

AI plans the SDTM domains, drafts mapping rules and builds the transformation workflows from your study metadata in hours rather than weeks.

Improve efficiency

Datasets, Define-XML, annotated CRF and reviewer's guide are generated from one reviewed specification, so changes flow through every deliverable.

Reduce cost

Smaller teams deliver more studies: repetitive programming is automated, and conformance issues are found and fixed before submission.

Shorten time to submission

A single dry run takes the uploaded sources to a complete set of submission deliverables, so issues surface early instead of at the deadline.

Protect patient data

Our AI works from metadata and de-identified coded values only. Patient-level records are never sent to an AI model.

Keep experts in control

Every AI proposal is a draft. Qualified people review, change and approve it, and every decision is recorded in the audit trail.

Our Product

SDTM Studio

AI-assisted conversion of clinical trial data to CDISC SDTM — from raw EDC exports and external vendor data to submission-ready datasets, Define-XML, annotated CRF, reviewer's guide and validation report.

  • AI-drafted domain inventory, mapping rules and workflows
  • Visual transformation workflows with live previews
  • CDISC CORE conformance validation
  • One-click dry run to a complete set of deliverables
Learn more about SDTM Studio
SDTM Studio transformation workflow with the SDTM output preview
How it works

From raw data to submission package — with AI doing the first draft.

  1. 01

    Upload

    Load EDC exports, external vendor data, EDC metadata and the blank CRF.

  2. 02

    AI drafts

    AI proposes the SDTM domains and drafts each domain's mapping and workflow, test-run on your data.

  3. 03

    Review

    Your team checks every proposal against live previews, edits what's needed and confirms.

  4. 04

    Deliver

    Generate validated SDTM datasets, Define-XML, annotated CRF and reviewer's guide.

Our Approach

AI where it helps. Evidence where it matters.

Large language models are good at reading metadata and proposing mappings. Regulatory deliverables need determinism and traceability. Our products combine both: AI drafts the specification, and auditable engines execute it.

How we protect data
  • Privacy by designOnly metadata and de-identified coded values reach the AI; identifiers and free text are withheld, and every request is scanned and logged.
  • Human in the loopAI output is always a draft that qualified people review and approve.
  • Deterministic executionApproved specifications run as reviewable programs, exportable in Python, R and SAS.
  • Full traceabilityWho changed what, when and why — for specifications, runs and approvals.
  • CDISC standardsSDTM/SDTMIG, Controlled Terminology, Define-XML 2.1 and CDISC CORE validation.
About eClinTrial AI

An AI-native company for clinical data.

eClinTrial AI was founded on a simple idea: the time between collecting clinical trial data and submitting it to regulators can be much shorter. We build AI into the core of clinical data processing and analysis, not as an add-on, to help sponsors bring therapies to patients sooner.

Our first product, SDTM Studio, automates the conversion of clinical trial data to CDISC SDTM. More tools across clinical data processing and analysis will follow.

AI-native

AI is built into the workflow from the first step, not bolted on.

Sponsor focused

We measure success by faster, cleaner submissions for sponsors.

Quality by design

Standards, validation and audit trails are part of every product.

Transparent

Every AI suggestion comes with its rationale and is open to review.

Get started

See SDTM Studio on your study.

Tell us about your upcoming submission and we’ll set up a walkthrough of SDTM Studio with your own data structures.