Security, privacy, and compliance are core to TrialNexus — not an afterthought.
TrialNexus is designed for enterprise clinical trial operations. We combine deep auditability with AI‑native workflows so teams can move fast without compromising control.
Security documentation, validation packs, and architecture details are available under NDA. For requests, contact sales@trialnexus.ai.
Data is encrypted in transit and at rest, with strict key management and least‑privilege access.
Role‑based access control, SSO support, and granular permissions across study teams.
Immutable, time‑stamped audit logs aligned to 21 CFR Part 11.
IQ/OQ/PQ documentation and validation support for GxP workflows.
Explainable outputs, confidence thresholds, and human‑in‑the‑loop controls.
Vulnerability management, incident response playbooks, and continuous monitoring.
TrialNexus aligns to the standards and regulatory expectations that govern clinical trials.
We provide compliance and validation documentation for sponsor and CRO audits.
Customer data is used solely to deliver the TrialNexus service. We do not train foundation models on customer data without explicit agreement.
Retention periods, data residency, and deployment models (including private cloud options) are configurable to meet enterprise requirements.
We provide a full security and validation packet under NDA.