nPhase AI
nPhase provides an AI-native clinical data platform that unifies data management and statistical computing into a single data fabric spanning the entire clinical data lifecycle. The platform automates SDTM mapping with 88%+ accuracy, compresses submission timelines from four months to weeks, and has been deployed at a top-5 pharma sponsor migrating 90+ live pivotal trials.
- Healthcare Technology
- Artificial Intelligence
- Software Only
- Data & Analytics
Funding
Raised to date
$30MRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
across 1 round
$30M · Series D
Announced Nov 2026
Disclosed cumulative: $30M
Founders
Founder details are not available yet.
Product
Problem
Clinical trial data management is fragmented across numerous disconnected systems, requiring manual handoffs between data capture, standardization, analysis, and regulatory submission. This stitched-together vendor ecosystem creates reconciliation burdens, delays data freshness, and extends the time from last patient visit to regulatory submission by months.
Solution
nPhase provides an AI-native clinical data platform that unifies the Unified Data Management System (UDMS) and Statistical Computing Environment (SCE) into a single data fabric spanning the entire clinical data lifecycle. The platform ingests data from EDC, ePRO, labs, EHR, wearables, and 70+ other sources, standardizing it in real time against SDTM targets defined before collection. AI capabilities automate SDTM mapping across 59 domains, translate EHR codes to CDISC standards, convert SAS to R with clinical domain awareness, and compile safety cases automatically. The system delivers submission-ready packages with full computational provenance, compressing workflows that typically require four or more months into weeks.
Target Audience
Primary customers are pharmaceutical sponsors and contract research organizations (CROs) conducting clinical trials, particularly large enterprises running global pivotal studies. The platform also serves small and mid-size sponsors, academic research organizations, MedTech studies, and real-world data programs through its REDCap Cloud EDC offering.
Features
- Unified data fabric that connects CRF, non-CRF, EHR, labs, and wearable data through one architecture with a single provenance chain from capture to submission
- Real-time clinical model checks with cross-domain validation at point of entry, eliminating manual batch reports and retroactive end-of-study reconciliation
- AI-powered SDTM auto-mapping with 88%+ accuracy, trainable to 99% per customer deployment, with human-in-the-loop exception-based review
- Automated ADaM generation, TLF production, and integrated Pinnacle 21 validation with auto-remediation
- Immutable snapshots capturing input data, code, and environment state for full computational provenance and audit readiness
- SAS-to-R converter with clinical domain awareness for modernized statistical computing
- GxP-native governance with 21 CFR Part 11 compliance and immutable audit trails built into every layer