OpenTrial is a pipeline product. It is in design today, with early access opening to a small number of clinical trial sponsors and CROs in the second half of 2026. There is no live demo yet. Join the early access list to be among the first.
OpenTrial will bring the OpenLI agentic AI foundation to clinical trial Risk-Based Monitoring (RBM) lifecycles. Built on the same OpenLI Codex runtime that powers our shipping healthcare integration products — with the same governance, audit trail and dual-runner architecture, specialised for the clinical trial sponsor and CRO buyer.
Clinical trial Risk-Based Monitoring is shifting from spreadsheet-driven monitoring to real-time risk surfaces. AI-assisted RBM is the obvious next step, but the regulated nature of clinical trials means agentic systems must come with governance built in — not bolted on. That is exactly the OpenLI Codex thesis. OpenTrial applies it to the pharma sponsor and CRO buyer.
OpenTrial will inherit the OpenLI Codex governance posture: 7-tier RBAC, audit trails on every agent action, human approval gates, PII sanitisation hooks. Aligned with ICH-GCP and 21 CFR Part 11 expectations from day one.
Pharma buyers who already use OpenLI HIE, IMX Monitor or Integrai will have already done the OpenLI Codex security review. OpenTrial inherits that posture — one less procurement gate to clear.
OpenTrial is explicitly in the OpenLI roadmap as a v1 priority for 2026 H2. Early access opens to a small number of sponsors and CROs first; general availability follows once the early-access cohort has run real protocols on the platform.
The capabilities below are the planned scope of OpenTrial v1. They are not shipping today; they describe what early-access participants will see.
Will support: the full RBM lifecycle — risk identification, KRI definition, monitoring, escalation and close-out — as a versioned, auditable workflow.
Will support: agentic detection of protocol deviation patterns across sites, with confidence-scored findings reviewable by the central monitor.
Will support: central monitoring with AI-drafted signal reviews, surfaced as evidence-backed hypotheses for the central monitor to confirm or reject.
Will support: site-level risk scoring against KRI thresholds, with explainable contributing factors.
Will support: integration surfaces for the major Electronic Data Capture, Clinical Trial Management, and electronic Trial Master File systems.
Will support: multi-party trial governance — sponsor and one or more CRO partners on a single trial, with appropriate data and action visibility per party.
Will support: immutable audit trail of every agent action and every human decision. Designed for ICH-GCP and 21 CFR Part 11 alignment.
Will support: the same Claude Agent SDK + OpenAI Codex SDK dual-runner architecture as the rest of the OpenLI portfolio. No vendor lock-in for the AI substrate.
Will support: whitelabel deployment for CROs who want to offer OpenTrial under their own brand to their own sponsor clients.
OpenTrial is being built on the same OpenLI Codex foundation that powers every shipping product on the OpenLI family tree. The runtime, the governance framework, the audit trail, the dual-runner architecture — all already in production today across our healthcare integration cluster.
OpenTrial early access opens in 2026 H2. Join the list for sponsors, CROs, and biotech operators who want to be in the early-access cohort.