Clinical data platform
End-to-End Clinical Research Data, in Real-time.
Replace fragmented point solutions and workflows with a unified, real-time AI-native platform that delivers enterprise-grade data across the entire clinical lifecycle.
Introducing SCE
Automated SDTM-mapping → ADaM → TLF → P21
validation to help fast-track your submission.
validation to help fast-track your submission.
Measurable impact
Top-5 Pharma unifies global clinical data management migrating over 90+ live studies.
A top-5 Sponsor partnered with nPhase to build UDMS 2.0 from the ground up —replacing multiple legacy systems with a single, end-to-end clinical data management platform. Migrating over 90+ live global pivotal trials and replacing 13 siloed vendor solutions.
UAT Error Rate
60% Reduction
Study Build (Oncology)
22% Faster
Data Freshness
Real-time
Site Burden
75% Fewer Logins
Source:
Client presentations at SCOPE 2026 and DPHARM 2025
Client presentations at SCOPE 2026 and DPHARM 2025
Vendor Simplification
13
1
From 13 disconnected systems to a single unified platform.
Enterprise Migration
90+
Live Pivotal Trial Migrations Underway
Ai Enabled offerings overview
Two Engines, one AI-Ready Data Fabric
UDMS gives you real-time clinical data you can trust. SCE gives you submission-ready deliverables you can defend.
Together, they replace the fragmented stack standing between your trial data and regulatory filing.
SCE
NEW AI PLATFORM
Statistical Computing Environment
From raw clinical data to submission-ready, automated
From raw clinical data to submission-ready, automated
SDTM Auto-Mapper
Automated ADaM dataset generation & TLF creation
Integrated Pinnacle 21 validation with auto-remediation
SAP → ARS conversion
Auto-CSR generation
SAS → R Migrator
Raw Study Data → FDA Ready Data
Statistical Computing Workbench
(R, SAS, Python)
(R, SAS, Python)
UDMS
Unified Data Management System
Real-time, end-to-end clinical data platform
Real-time, end-to-end clinical data platform
Real-time data with <3 min latency powering enterprise analytics and insights
Integrates 70+ data sources and harmonizes to a common datamodel
Automated Query Management with Bi-directional data flow
Replaces 13+ point solution vendors
automed edit checks powered by metadata
Data Mgmt
Analytics
EDC / eCOA
eSource / EHR
Interoperability
Compliance
Safety
End-to-End Data Lifecycle
Every stage. One Data Fabric
From the moment data is captured at a site or wearable to the moment it is submission-ready.
Fully standardized, traceable, and audit ready. Never losing provenance. All in real-time.
Fully standardized, traceable, and audit ready. Never losing provenance. All in real-time.
[ 01 ]
Acquisition
EDC, ePRO, labs, EHR, wearables, and 70+ other data sources
[ 02 ]
Harmonize Data
Real-time clinical models, SDTM targets defined pre-collection
[ 03 ]
Analytics & AI/ML
Analytics, monitoring, signal detection, query management, bi-directional data flow
[ 04 ]
Pre-validation
Automated Raw Data → SDTM → ADaM →TLF
[ 05 ]
Validation
P21 Validation and Auto-Remediation
[ 06 ]
Submit & Reuse
Submission-ready packages with full computational provenance
[ 01 ]
Acquisition
EDC, ePRO, labs, EHR, wearables, and 70+ other data sources
[ 02 ]
Harmonize Data
Real-time clinical models, SDTM targets defined pre-collection
[ 03 ]
Analytics & AI/ML
Analytics, monitoring, signal detection, query management, bi-directional data flow
[ 04 ]
Pre-validation
Automated Raw Data → SDTM → ADaM →TLF
[ 05 ]
Validation
P21 Validation and Auto-Remediation
[ 06 ]
Submit & Reuse
Submission-ready packages with full computational provenance
Data integrity
UDMS
Define standards before collection. Eliminate reconciliation forever.
Every data element's SDTM landing place is defined at study setup. CRF and non-CRF data flow through the same clinical models in real time, with cross-domain validation at the point of entry.
Real-time clinical model checks replace manual batch reports
75–80% of clinical trial data is non-CRF → unified from day one
On-demand snapshots delivered to programmers in one click
Statistical computing
SCEFrom Validated Data to Submission-ready deliverables. No handoff required.
AI-powered SDTM auto-mapping, automated ADaM generation, TLF production, and integrated Pinnacle 21 validation. All governed, all reproducible.
60-80% faster time to submission from LPLV
Immutable snapshots capture input data, code, and environment state
SAS-to-R converter with clinical domain awareness
Intelligence
UDMS + SCE
AI woven in at every stage. Governed at every output.
Intelligence that works inside the regulated workflow — automating SDTM mapping across 59 domains, translating EHR codes to CDISC standards, converting SAS to R with clinical domain awareness, and compiling safety cases automatically.
88%+ auto-mapping accuracy, trainable to 99% per customer deployment
Human-in-the-loop by design — exception-based review, not blind trust
Every AI output captured in immutable snapshots for audit
Why nphase AI
Designed for how research teams actually work to overcome stitched-together vendor ecosystems.
A single data fabric designed from the ground up for the complete clinical data lifecycle.
One Data Fabric
CRF, non-CRF, EHR, labs, wearables — every source enters through one architecture removing batch handoffs. One provenance chain from capture to submission.
Capture Through Submission
The only provider that owns both data management and statistical computing, Mastering your data from Data Capture → Submission.
AI Inside the Workflow
SDTM auto-mapping, clinical language model, EHR translation, safety compilation — AI woven into regulated workflows.
Proven at Enterprise Scale
45+ de novo Top-5 Sponsor studies live, 90+ live migrations underway, 70-day median oncology builds. Global infrastructure trusted by one of the world's largest sponsors.
GxP-Native Governance
21 CFR Part 11 compliance, immutable audit trails, computational provenance, and Pinnacle 21 validation built into every layer.
Vendor Consolidation
Replace 13 point solutions with one platform. Fewer contracts, fewer integrations, fewer validation events, fewer vendor management headaches.
Our evolution
Over a decade of innovation to emerge as the industry's benchmark for end-to-end clinical data.
nPhase is the next chapter of a company that spent over a decade earning the trust of the world's most demanding clinical research organizations.
A platform built with a pedigree.
A platform built with a pedigree.
2016
GxP-Native Governance
Born out of research, nPhase and Vanderbilt enter into a pioneering licensing collaboration to bring cloud technologies globally to support academic researchers, MedTech and RWE studies with REDCap Cloud.
2019
Global Scale
From our early roots nPhase rapidly evolved REDCap Cloud into a global CDMS supporting 500+ customers, including 75% of the top-20 Pharma and 100% of the top-5 CRO's.
2025
UDMS
Our global delivery of UDMS, supporting a Top-5 Sponsor to streamline Clinical Research across 100's of Phase 2 & 3 studies across 1000's of sites worldwide. (Generally available: Q4 2026)
2026
nPhase.ai
The next chapter of our evolution, bringing the first purpose-built, AI-native Statistical Computing Environment (SCE) for life sciences.
Global security & Compliance
Built for global regulatory compliance.
Validated by industry
Developed for Industry.
Validated by Top Pharma.
Learn more about how data quality across the lifecycle can
improve every aspect of your R&D strategy.
improve every aspect of your R&D strategy.
