🧪 pack: clinical-trials-pack

Run decentralized trials without the 21 CFR Part 11 audit-trail nightmare.

Building a CTMS, EDC, eCOA, ePRO, eConsent, or any clinical-trial platform? GreatCTO auto-attaches clinical-trials-pack (paired with bio-data) for ICH-GCP E6(R3), 21 CFR Part 11 audit trail + e-signatures, CDISC SDTM/ADaM, FHIR R5/HL7/OMOP/DICOM conformance, de-identification (Safe Harbor or Expert Determination ≤ 0.04), and AE/SAE 24h reporting.

$ npx great-cto init All packs ↗
Auto-attach signals

Detected by CLI when:

clinical trial · CTMS · EDC · eCOA · ePRO · eConsent · IRB · CDISC · FHIR · HL7 · DICOM · OMOP · genomics

The pack rides on top of your base archetype (web-service, ai-system, fintech, …) — it doesn't replace it. Auto-injects reviewer agents into the pipeline + opens human gates listed below.

Reviewer agents activated

2 specialists added to the pipeline.

01 · clinical-trials-reviewer

ICH-GCP E6(R3) + 21 CFR Part 11 + CDISC + IRB + AE/SAE + DCT

02 · bio-data-reviewer

FHIR R5 + HL7 + OMOP + DICOM + VCF/BAM/CRAM + Safe Harbor de-id + GA4GH DUO

Human gates introduced

3 new gate types on top of gate:plan + gate:ship.

GateOwnerTrigger
gate:irb-readyclinical lead + regulatorybefore IRB submission
gate:part11-validationindependent QA leadbefore production go-live
gate:deidentificationstatistical expertif Expert Determination used
Required artefacts before senior-dev claims tasks

10 concrete deliverables.

EVAL suite required

6 golden-set scenarios shipped as templates.

Each EVAL has ≥5 test cases, pass threshold, regression interpretation, cross-refs to TM + gates. Run via your existing test framework.

Regulatory surface covered

7 standards / regulations addressed.

ICH-GCP E6(R3) 21 CFR Part 11 EU GMP Annex 11 CDISC SDTM-IG + ADaM-IG FDA DCT guidance (2024) HIPAA Privacy Rule 164.514 GA4GH DUO
Real-world examples

20 companies in this space.

ICON plc
Global CRO for clinical trials
publicIE
IQVIA
Human data science for healthcare
publicUS
Science 37
Operating system for decentralized trials
publicUS
Tempus AI
Precision medicine via AI + clinical data
publicUS
Veeva Systems
Cloud software for life sciences
publicUS
Flatiron Health
Oncology EHR + real-world evidence
subsidiaryUS
Medable
Decentralized clinical-trial platform
series-dUS
Castor
Modern clinical-trial data platform
series-cNL
Florence Healthcare
Site enablement for clinical trials
series-cUS
Reify Health
Clinical-trial enrollment platform
series-cUS
Curebase
End-to-end clinical-trial execution via software
series-bUS
ObvioHealth
Virtual clinical-trial platform
series-bUS
Owkin
AI biotech for trials + drug discovery
series-bFR
THREAD
Decentralized clinical-trial platform
series-bUS
AOA Dx
Blood test for early ovarian cancer detection
seedUS
Infiuss Health
Two-sided marketplace for medical research
seedCM
Medplum
Open-source API-first electronic health record system
seedUS
Nest Genomics
Software for genetics integration into clinical care
seedUS
Syntra
Personalized and automated electronic health records
seedUS
Parexel
Biopharmaceutical services + CRO
privateUS

Listed companies operate in this space. Inclusion is based on publicly available product descriptions and does not imply endorsement of or by GreatCTO.

FAQ

Common questions about clinical-trials-pack.

When does clinical-trials-pack auto-attach?
When the CLI detects these signals in your repo: clinical trial · CTMS · EDC · eCOA · ePRO · eConsent · IRB · CDISC · FHIR · HL7 · DICOM · OMOP · genomics. Override anytime by editing packs: in PROJECT.md.
What human gates does clinical-trials-pack introduce?
gate:irb-ready (clinical lead + regulatory), gate:part11-validation (independent QA lead), gate:deidentification (statistical expert). These layer on top of the standard plan/ship gates.
What if my project doesn't match these signals exactly?
You can manually add the pack name to PROJECT.md or run /migrate to re-run detection with updated rules.
30 seconds

Drop GreatCTO into any repo — clinical-trials-pack attaches automatically.

$ npx great-cto init
no signup·runs locally·pay your own API