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No-code SDTM, ADaM, & TFLs for clinical development.

Automated workflow. Verifiable results.

Upload raw clinical data, map source to standard, and let CTIPAI generate the specs from those mappings — not a black box. Every deliverable is built twice, compared automatically, and ready for review.

Join the waitlist Explore SDTM & ADaM

21 CFR Part 11 designed-in
Raw data in · specs from mappings
No SAS license required

Automated workflow · verifiable results

DEV ↔ QC · compare · verify

One deliverable, built twice independently — then compared and verified automatically.

The problem

Clinical development is expensive, slow, and siloed.

SDTM starts from raw clinical data, but most teams still hand-code mappings and specs study by study.
Specs lag the mappings — written in parallel docs that drift from what actually runs.
Independent double-programming doubles effort and depends on manual reconciliation.
Compliance, audit trails, and study isolation are often bolted on after the fact.

What teams still pay for

Raw data → hand specs

Upload is easy; the mapping and spec work is not

Opaque pipelines

Hard to see what mapping produced the deliverable

Slow QC cycles

Double work, manual reconciliation

Little reuse

The same pipeline rebuilt study after study

CTIP collapses that overhead: raw clinical data in, transparent mappings, specs generated from those mappings, and verifiable results — compliance built in.

Product

Automated workflow. Verifiable results.

CTIP automates the clinical data pipeline without hiding the work. You upload raw clinical data and map it in the UI; CTIPAI generates the specs from those mappings. Builds are independent. Agreement is recorded — so results are reviewable, not opaque.

No-code by design

Upload raw clinical data, author mappings in the UI, and let CTIPAI generate the specs — no terminal required.

Not a black box

Mappings are visible, reviewable, and editable. Specs are generated from those mappings — you see what runs before it ships.

AI-assisted, human-owned

Suggestions arrive with confidence scores. Your team accepts, adjusts, or overrides. Control stays with you.

Verifiable by construction

Every deliverable is built twice independently, compared automatically, and backed by evidence — not faith.

Compliant & isolated

Per-study isolation, full audit trails, and e-signature workflows designed for regulated clinical work.

Standards that stay current

Versioned libraries keep SDTM and ADaM conformance up to date as guidance evolves — pick, don’t rebuild.

Where we start

SDTM, ADaM, and TFLs first. The full lifecycle next.

We start where clinical data work is hardest and most mandatory — turning raw clinical data into standards and analysis datasets, with mappings you can audit, specs generated from those mappings, and QC you can trust. The rest of the study pipeline follows on the same foundation.

SDTM

Core module

Upload raw clinical data and author source-to-standard mappings in the UI — not a black box. CTIPAI generates the SDTM specs from those mappings, then produces clean standard datasets ready for review, QC, and the next step toward submission.

Upload raw clinical data — not pre-written specs
Map source to standard in a transparent UI
CTIPAI generates the SDTM specs from those mappings
Independent DEV and QC so results come with proof

Raw data → Map → Specs from mappings → Build → Validate → Deliver

ADaM

Core module

Move from standard data to analysis-ready datasets that match the study plan — with independent QC built in, so results are ready for tables, listings, and review.

Analysis-ready datasets aligned to how the study is planned
Consistent logic for populations, windows, and safety signals
Standards stay current as industry guidance evolves
Independent QC that proves the answer, not just produces it

Study plan → Derive → QC compare → Sign-off

Coming next

And we will do more.

The same automated, verifiable method grows into writing, statistics, outputs, and submission packaging — so clinical teams stop handing work between disconnected tools.

Get notified

Protocol & analysis plan authoring
Tables, figures & listings
Data transfer agreements & e-sign
Randomization workflows
Submission package assembly
Trial intelligence across studies

What you get

One platform. Every critical handoff.

Start with SDTM from raw clinical data — mappings you own, specs CTIPAI generates. Expand into writing, outputs, and submission as modules open — without switching tools mid-study.

Core conversion first. Authoring, outputs, and packaging follow.

Core

SDTM conversion

Upload raw clinical data, map source to standard, and generate specs from the mappings — guided by AI, owned by your team.

Core

ADaM derivation

Analysis-ready datasets that follow the study plan, ready for review and reporting.

Core

Independent QC

Two separate builds, compared automatically — so verification is evidence, not hope.

Tables & listings

Reusable templates for the outputs biostats and medical review need most.

Analysis plan authoring

Structured plans that stay connected to how data is derived and reported.

Protocol generation

Faster first drafts grounded in real trial patterns — not a blank page.

Data transfer agreements

Author, review, and sign transfer agreements with a clear audit trail.

Randomization

Reproducible assignment workflows with dual sign-off when you need it.

Trial intelligence

Designs, endpoints, and eligibility patterns drawn from study reference material.

Regulated trust layer

Audit trails, e-signatures, and study isolation designed for regulated work.

Ready to modernize how SDTM and ADaM get done?

Join early access for priority invites as CTIP opens to design partners.

Join the waitlist

Early access

Be first when SDTM and ADaM open.

Get founding-cohort access, product updates, and priority invites — before general availability.