TrialNexus is the AI operating system for clinical trials.
We turn protocols into USDM and deploy compliant artifacts directly into your EDC.
Cut database build from months to days and reach lock faster.
Behind every trial that reaches a patient, there are data managers who can read a 200-page protocol and see the database it needs to become. Biostatisticians who catch signal in noise. Clinical operations teams who orchestrate a thousand moving parts across a hundred sites in a dozen countries.
This expertise is extraordinary.
It's also being wasted.
The knowledge to run trials faster, cheaper, and better already exists inside your organization. TrialNexus turns it into governed, traceable data flows that move straight into your EDC.
We provide pilot metrics, audit trails, and validation documentation to qualified enterprise teams during evaluation.
IQ/OQ/PQ documentation, traceability matrix, and audit-ready SOP mappings.
Cycle-time reductions, query resolution performance, and time-to-first-build benchmarks.
Control narratives, audit logs, and 21 CFR Part 11 evidence under NDA.
TrialNexus is a unified AI execution orchestration platform spanning the full clinical trial lifecycle. USDM-centric. CDISC-native. Each agent masters a domain. They share context across phases. You don't work for the agents. The agents work for you.
We're starting where the pain is worst: Data Management.
See what it looks like when your team gets superpowers.
Focused on data management first, with the core workflow already live end‑to‑end.
USDM extraction with confidence scoring and human review.
CDASH‑aligned eCRFs with validation logic and edit checks.
Direct deployment into live EDC environments.
Standards‑aligned SDTM mappings with provenance.
Analysis datasets generated from USDM context.
Auto‑triage and recommended resolutions with audit trails.
Variable‑level AI reasoning and traceability.
Full oversight, augmented, or autonomous — you choose.
Industry‑first mobile‑first UX for DMs on the move.
One platform, three stakeholder wins — with shared auditability.
Faster study start‑up, fewer escalations, and real‑time operational visibility.
Standards‑aligned SDTM/ADaM outputs with full provenance and traceability.
Audit trails built in, documented workflows, and submission‑ready artifacts.
TrialNexus normalizes protocol intent into USDM, generates compliant artifacts, and orchestrates deployment into your live EDC environment.
Representative views from the data management workflow. Full demo available on request.
Auto-extracted USDM with confidence scoring and human review.
CDASH-aligned eCRFs with validation logic and edit checks.
SDTM/ADaM mappings and Define-XML built from USDM context.
Watch a real protocol go from upload to deployment in minutes.
Not a wrapper on ChatGPT. Not a chatbot for doctors. A purpose-built operating system for the teams who design, conduct, and submit clinical trials.
Built from the ground up on CDASH, SDTM, ADaM, and Define-XML. USDM-centric architecture ensures consistency from protocol to submission.
Every decision logged with provenance and reasoning. Built for 21 CFR Part 11 and ICH E6(R3) expectations.
You set the boundaries. Full oversight, augmented, or autonomous — the agents respect your workflow preferences.
Seamless connectivity with existing Electronic Data Capture platforms. Medidata Rave integration live. Veeva Vault CDMS integration live. Your existing infrastructure, orchestrated.
Full provenance tracking and confidence scoring for every automated decision. Every reasoning chain preserved. Autonomous but never opaque.
Designed to integrate with your existing technology ecosystem. Not a replacement for your EDC — the orchestration layer that makes everything work together.
We're partnering with CROs and pharmaceutical companies who believe their teams deserve better tools.