Your site, inspection-ready by default.
One system of record for your studies — every change captured with who, what, when, and why.
Designed and tested against 21 CFR Part 11 · built for sites running 1–25 studies · from $299/mo, no seat fees · your data exports anytime.
The dozen places a site keeps its trial — or one record.
One system of record.
Every change accounted for — who, what, when, and why.
Keeps running alongside the systems you don’t move — your sponsor’s EDC, your IRB’s portal, and your accounting.
One record for the whole site.
Built ground-up as a CTMS — one schema, one audit log, one role system. It sits alongside your sponsor’s EDC, not on top of it: the integration-open command center for site operations, regulatory, and finance.
Subjects & visits
Full subject lifecycle with protocol-window visit scheduling — enrollment, adverse events, deviations, and concomitant meds, in one view across every active study.
Delegation & access
The delegation log drives system permissions — who can do what is governed by the same record an inspector reviews on day one.
Supports Form FDA 1572Audit trail & e-signatures
Every action logged with user, timestamp, and reason for change. Native PI e-signatures capture signing meaning — exportable for monitors and sponsor submissions.
21 CFR §11.10(e) · §11.50The two documents an inspector asks for first.
Nexrial keeps both current automatically. The delegation log governs system access; the audit trail records every edit with its reason. No reconstructing binders the night before.
Sample records, de-identified — new entries append live above, the way a working trail grows. Audit entries can’t be edited or switched off — that’s the point of §11.10(e). How Nexrial implements Part 11 →
From $299/month per site — unlimited users, no seat fees, no setup fee, cancel anytime.
Founding sites: 50% off, locked for life →Built inside site operations, not beside them.
The people behind Nexrial prepare delegation logs, sit through monitoring visits, and invoice sponsors in working clinical-research operations. The system exists because the spreadsheet-and-binder version of that job kept breaking — not because a software company went looking for a market.
Tyrian has spent his career in clinical research operations — running study visits, preparing for monitor and sponsor reviews, and closing out the billing behind them. Nexrial is the system he needed on those days and couldn’t buy.
Built inside a working research site — real studies run on Nexrial every day.
Questions, before or instead of a call? Write to [email protected] — it reaches the people who build the product.