⚠ 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 Statistically Consistent Regulation-Aware

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

01 · Select & Configure
🗂️
Choose Data Type & Protocol
Select SDTM or ADaM, choose a clinical protocol and configure generation settings.
Select Type Synthetic Data Generation · Home
Choose between Clinical Study Data (SDTM) or Analysis Datasets (ADaM) — CDISC-aligned from the first step.
Configure Protocol Selection & Generation Settings
Select a clinical protocol — indication, phase, and site details auto-populate. Set subject count and target domains to generate.
02 · Generate
⚡
Dataset Generation in Seconds
Statistically consistent, rule-compliant synthetic data generated on demand.
Generating Dataset Generation Progress
Real-time generation progress — 100% complete in 6 seconds at 51.5 records/s. No waiting, no manual data handling.
Results · Validation Passed 4,648 Rows · 26 Domains · 0 Errors
Validation passed — domain data table with per-domain row counts and downloadable CSV files. Derive analysis datasets coming soon.
03 · Reports
📊
Trial Metadata · Data Quality · Protocol Adherence
Comprehensive reporting across conformance, adherence, and subject profiles.
Reports · Trial Metadata Protocol · Generator Version · SDTM IC
Full trial metadata — study ID, protocol, generator version, SDTM IC version, treatment arms, sites and subject-level summary.
Reports · Data Quality Conformance by Category · Quality Checks
Structural, temporal, terminology, coherence and derived checks — FDA submission rules and domain structure validation side by side.
Reports · Protocol Adherence Visit Compliance · Deviations · Dose Compliance
76.7% visit compliance, 37.2% dose compliance — deviations categorised by type, visit and treatment arm for full protocol review.
04 · Subject Profiles
👤
Per-Subject Demographics, Timeline & Events
Drill into any synthetic subject — exposure, adverse events, deviations, and full visit timeline.
Subject Profiles · List 30 Synthetic Subjects · Searchable
30 searchable synthetic subjects across sites — click any to drill into full demographics, timeline, and clinical events.
Subject · Demographics & Timeline Site · Arm · Consent → Randomisation → Dosing
Full subject record — demographics, randomisation arm, consent date and a chronological event timeline from screening to follow-up.
Subject · Exposure & Adverse Events Dosing Schedule · AE Severity · Causality
Treatment exposure schedule and adverse events with severity, causality, and outcome — realistic data for end-to-end safety testing.
✓ The Outcomes
What Teams Achieve with TrialGen™
100%
Privacy-safe testing — zero patient data exposure
<10s
Dataset generation — 4,648 rows across 26 domains
Earlier
Edge case and AE detection before live data arrives
Faster
Validation cycles — proactive, not reactive