Mapping-driven by design
Upload raw clinical data, author mappings in the UI, and let CTIP generate the specs from those mappings.
Early access · Now open
Click-to-code
SDTM, ADaM, & TFLs
for clinical development.
You author. CTIP programs. You upload raw clinical data and author your mappings in the UI – including the conditional and derived logic – through method builders instead of syntax. CTIP generates the specs from those mappings and writes the code. You bring the clinical judgment.
- 21 CFR Part 11 designed-in
- Raw data in · specs from mappings
- No SAS license required
Automated workflow · verifiable results
DEV ↔ QC · compare · verifyOne 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
01
Raw data → hand specs
Upload is easy; the mapping and spec work is not
02
Opaque pipelines
Hard to see what mapping produced the deliverable
03
Slow QC cycles
Double work, manual reconciliation
04
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; CTIP generates the specs from those mappings. Builds are independent. Agreement is recorded — so results are reviewable, not opaque.
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 repeatable outputs on one platform. Mappings you can audit, specs generated from those mappings, and independent QC you can trust — for every deliverable, with executable programs and their associated log files.
SDTM
AvailableUpload raw clinical data and author source-to-standard mappings in the UI — not a black box. CTIP 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
- CTIP generates the SDTM specs from those mappings
- FDA CDISC standard compliance checks built-in
- Submission package ready with aCRF.pdf, define.xml, cSDRG.pdf
- Independent DEV and QC so results come with proof
Raw data → Map → Specs from mappings → Build → Validate → Deliver → Sign-off
ADaM
AvailableMove 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
- FDA CDISC standard compliance checks built-in
- Submission package ready with define.xml and ADRG.pdf
- Independent QC that proves the answer, not just produces it
SAP and SDTM → Specs → Derive → QC → Compare → Sign-off
TFLs
AvailableTables, 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
- Reporting for ad hoc analyses
- Outputs stay connected to the mappings and specs that produced them
ADaM → Template → Build DEV/QC → Compare → Deliver → Sign-off
What's next
Get notifiedFull study lifecycle next:
- Protocol & analysis plan authoring
- Data Management Plan authoring
- Data transfer agreements & e-sign
- Visualization with drill-down features for data review
- Statistical Analysis Plan authoring
- Randomization schedule and workflow
- Study Integration
- Team review workflow
- Trial intelligence across studies
What you get
One platform. Every critical handoff.
SDTM, ADaM, and TFLs today — mappings you own, specs CTIP 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.
Next
Analysis plan authoring
Structured plans that stay connected to how data is derived and reported.
Next
Protocol generation
Faster first drafts grounded in real trial patterns — not a blank page.
Next
Data review
From the individual data points to aggregated summaries with drill-down features to link across data domains.
Next
Data transfer agreements
Author, review, and sign transfer agreements with a clear audit trail.
Next
Randomization
Reproducible assignment workflows with dual sign-off when you need it.
Next
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.
Next
Much more to come…
Ready to modernize how SDTM, ADaM, and TFLs get done?
Join early access for priority invites as CTIP opens to design partners.
Early access
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Founding-cohort access, product updates, and priority invites — before general availability.
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