Early access · Now open

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 & TFLs

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. TFLs sit on the same stack.

Available now

SDTM, ADaM, and TFLs — one connected path.

Raw clinical data to standards, analysis datasets, and reportable outputs on one platform. Mappings you can audit, specs generated from those mappings, and independent QC you can trust — for every deliverable.

SDTM

Available

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 analysis.

Upload raw clinical data — not pre-written specs
Map source to standard in a transparent UI
Built-in methods for derivation, aggregation, and transformation
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 → Sign-off

ADaM

Available

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

Analysis-ready datasets aligned to how the study is planned
Built-in algorithms for data derivation and analysis
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

TFLs

Available

Tables, figures, and listings built from the analysis datasets you already verified — same dual-build method, reusable templates, outputs that stay tied to the mappings and specs upstream.

Tables, figures, and listings from the analysis datasets you already trust
Automatically generate a TOC of all TFLs
Review outputs in one secure, centralized workspace
Reusable templates for biostats and medical review outputs
Same dual-build method — produce once for DEV, once for QC, compare
Outputs stay connected to the mappings and specs that produced them

ADaM → Template → Build DEV/QC → Compare → Deliver → Sign-off

What's next

Full study lifecycle next.

Protocol and plan authoring, data management and statistical analysis plans, study integration, transfer agreements, randomization, submission packaging, and trial intelligence — on the same automated, verifiable foundation.

Get notified

Protocol & analysis plan authoring
Data Management Plan
Statistical Analysis Plan
Study Integration
Team Review Workflow
Data transfer agreements & e-sign
Randomization workflows
Submission package assembly
Trial intelligence across studies

What you get

One platform. Every critical handoff.

SDTM, ADaM, and TFLs today — mappings you own, specs CTIPAI generates, dual-build QC on every deliverable. Protocol, transfer, randomization, and submission follow on the same foundation without switching tools mid-study.

Core: SDTM, ADaM, TFLs, and QC. Lifecycle modules come next.

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

Tables, figures & listings

TFLs built from analysis datasets with the same dual-build QC — reusable templates for biostats and medical review.

Core

Independent QC

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

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.

Core

Regulated trust layer

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

Ready to modernize how SDTM, ADaM, and TFLs get done?

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

Join the waitlist

Early access

Get early access to SDTM, ADaM, and TFLs.

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