⚠ The Challenge

Clinical validation is limited by data access.

⏱

Validation Delays

Workflows stall when real datasets are unavailable, restricted, or incomplete at critical stages.

📉

Insufficient Test Coverage

Testing on limited data leaves edge cases and anomalies undetected until late in the trial.

🔒

Privacy Constraints

Compliance and patient-privacy rules prevent data from being shared freely across teams.

✦ The Platform
TrialGen™
Synthetic Clinical Data Generation
CDISC-Aligned Privacy-Safe Traceable Reproducible

Generate realistic synthetic clinical datasets on demand — enabling teams to test, validate, and refine workflows without exposure to real patient data.

01 · Choose & Configure
🗂️
Start from the Protocol
Pick a ready-made catalog study or bring your own CDISC USDM or PDF protocol — reviewed field by field against its source.
Choose Catalog Protocol or Your Own
Two ways in — a ready-made catalog study or your own protocol. SDTM today, with ADaM analysis datasets planned.
Upload Protocol CDISC USDM JSON · Protocol PDF
Upload a USDM file or a protocol PDF — review each extracted value with its source quote and page, then approve it.
Configure Study · Subjects · Datasets · Seed
Choose the study, how many subjects and which datasets — the same study and seed always reproduce the same data.
02 · Generate
⚡
Deterministic, Validated Generation
Seeded and replayable — every run is conformance-checked and receipted with a SHA-256 of every file.
Generating Live Run Progress
Live progress through every stage — randomisation, visit schedule, MedDRA and CDISC terminology coding, and conformance validation.
Results · Conformance Passed 38 SDTM Domains · 190,566 Rows
38 SDTM-IG v3.4 domains with zero errors or warnings — one submission package with Define-XML 2.1, Dataset-JSON and XPT.
03 · Reports
📊
Quality · Adherence · Fidelity · Traceability
Seven report views on every run — from subject flow and conformance to population fidelity and provenance.
Reports · Overview Subject Flow · Arms · Sites
Where every subject went — 266 screened, 150 randomised across two arms at 19 sites in 16 countries, through to study completion.
Reports · Data Quality 182 Conformance Checks · 38 Datasets
Every dataset checked on every run — conformance passed with zero errors and zero warnings across 190,566 records.
Reports · Adherence Visits · Doses · Deviations
Visit attendance, dose compliance and simulated protocol deviations — by subject, type and arm — to exercise protocol-review workflows.
Reports · Fidelity Population Fidelity Score
Scored against the trial's published baseline population — 95.4 / 100, with all 330 checks inside tolerance.
Reports · Traceability Protocol → Rule → Define-XML
Every variable traced from the protocol, through the rule that generated it, to its Define-XML definition.
04 · Subject Profiles
👤
Per-Subject Demographics, Timeline & Events
Drill into any synthetic subject — exposure, adverse events, medications, deviations and the full visit timeline.
Subject · Record Arm · Demographics · Consent → First Dose
Open any subject for their whole record — arm, demographics, consent and first dose, deviations and days on treatment.
Subject · Timeline Study Drug · AEs by Severity · Medications
One timeline by study day — study drug, adverse events by severity, concomitant medications, visits and deviations.
✓ The Outcomes
What Teams Achieve with TrialGen™
100%
Privacy-safe testing — zero patient data exposure
30+
SDTM domains — Define-XML, Dataset-JSON, XPT and CSV
Earlier
Edge case and AE detection before live data arrives
Faster
Validation cycles — proactive, not reactive