Statistical Computing Environment for Clinical Research
From raw clinical data to submission-ready. Automated.
Reduce time to submission by months, with full audit trails and traceability.
WHY SCE
AI you can validate. AI you can trust.
Each capability replaces weeks of manual programming to accelerate time to submission.
Automated SDTM Mapping
>90% first-pass accuracy with human-in-the-loop review. Continuous learning from corrections builds a knowledge base that improves with every study.
Last-Mile Automation
SDTM → ADaM and ADaM → TLF automation — the workflows competitors haven't solved yet.
Multi-Language Workspaces, On Demand
Self-service environments for SAS, R, and Python in one governed workspace — no migration headaches when an M&A event brings in a different language.
Pinnacle 21 Validation with Auto-remediation.
Pinnacle 21 integration for automated compliance validation. Full traceability from raw data to submission-ready package.
Reproducibility & Audit Readiness
Full computational provenance from ingestion to output: who did what, when, and exactly how. Reproducible on demand for any FDA inquiry.
Data in, clean regulatory artifacts out
Automated generation of regulatory artifacts SAP-> ARS conversion and CSR Generation.
Capabilities
[01]
Statistical Computing Workbench
Spin up SAS, R, Python, or VS Code in seconds — each in its own container, validated and version-controlled, so every environment is consistent, immutable, and reproducible by default. A utilization dashboard tracks spend by project, user, and resource, giving you self-service compute without losing financial control.
[02]
Raw data → SDTM → ADaM → TLF
The deliverables that decide your timeline — SDTM datasets, ADaM datasets, and TLFs — are generated end to end from governed rules and reproducible snapshots, not hand-coded study by study. The full chain is automated and reproducible, with human sign-off at every gate.
[03]
P21 Validation
Pinnacle 21 is wired directly into the pipeline: generated datasets are pushed to validation automatically and the report returns to your dashboard in minutes, enabling exception-based review without leaving the platform. A pre-P21 readiness check flags CDISC implementation-guide issues before official validation, and with auto-remediation, validation runs on every job — linking each error back to the mapping rule that caused it for a one-click fix.
[04]
SAP → ARS
Turn the Statistical Analysis Plan(SAP) into a CDISC Analysis Results Standard(ARS) — structured, machine-readable analysis definitions instead of logic buried in custom programs. AI drafts the ARS structures from the SAP; a biostatistician reviews and approves before anything executes.
[05]
CSR Generation
From analysis results to draft CSR, automatically and traceably. Generate Clinical Study Report content from structured analysis results — outputs retain lineage back to their ARS definitions and execution history, under the same audit trail, eSignatures, and version pinning as the rest of the platform.
[06]
SAS → R Migrator
Convert legacy SAS to R automatically and eliminate high-annual costs without rewriting your validated logic from scratch.
Built on Trust
Sits on top of your architecture.
Standardizes and automates everything downstream.
[01]
Security & Compliance
Access is controlled at the individual project level and managed through your own identity provider via single sign-on.
Data is protected, provisioned and governed allowing sensitive data to be shared, masked, and unblinded only under controlled, role-based permissions.
Data is protected, provisioned and governed allowing sensitive data to be shared, masked, and unblinded only under controlled, role-based permissions.
[02]
Reproducibility & Traceability
Every job automatically captures the exact version of its input data, code, environment, and output, to be reproduced on demand.
Native GitHub version control keeps every program and file tracked inside the platform.
Native GitHub version control keeps every program and file tracked inside the platform.
[03]
Enterprise Governance
Complex, multi-step computations run automatically at scale, configured to pause for human review and approval wherever your SOPs require it.
A global library of standards, code artifacts, and AI/ML models keeps work consistent across studies and therapeutic areas.
A global library of standards, code artifacts, and AI/ML models keeps work consistent across studies and therapeutic areas.
Better together
UDMS + SCE
UDMS manages the data. SCE transforms it. Together, they compress the journey from data capture to submission-ready package.
