One record for the whole site.
Built ground-up as a CTMS — one schema, one audit log, one role system. No plugins, no patchwork integrations to reconcile before a monitor arrives. Nexrial is the site-operations, regulatory, and financial layer; it sits alongside your sponsor’s EDC, not in place of it.
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) · §11.50Visit-to-invoice billing
Every completed visit becomes a billable line item against your CTA fee schedule — one-click invoice draft, unbilled-revenue dashboard, and AR aging. No spreadsheet, no charges missed 30 days later.
Deadlines & alerts
IRB renewals, protocol milestones, and sponsor deadlines surface on your dashboard and in your inbox — before they become findings.
Regulatory binder (eISF)
Document management with version control, approval workflows, and TMF completeness by study and section — so you know exactly where you stand before the monitor arrives.
AI assists with protocol summaries, AE narrative drafts, and eligibility checklists — every output is a clearly-marked draft for qualified human review. AI never signs a regulated record, and your data is never used to train third-party AI models. More on compliance →
Built for the site, not the sponsor.
The comparison is structural, not feature-for-feature. Enterprise systems are built for sponsors and CROs running portfolios. Nexrial is built for the people running the site — an integration-open, non-captive command center that runs alongside the sponsor EDCs you’re already given.
Often covered by a single study.
Most sponsors include a budget for site technology and CTMS costs in the trial budget — and Nexrial’s cost is often covered by a single study. We provide the documentation to include it as a line item in your study budget, so the system that runs your site is paid for by the trials it runs.
Veeva, OnCore, Medidata — built for sponsors and CROs. Platforms in this class typically run five to six figures a year, with procurement cycles, implementation teams, and a price the independent site was never meant to pay.
Built for the independent site running 1–25 studies — the segment the enterprise stack prices out. Live in one session, not one quarter.
Keep your eReg binder. Nexrial runs your site.
If your documents and sponsor connections already live in an eReg/eISF system, keep it — Nexrial doesn’t replace your binder. It adds the operational layer a document system doesn’t cover: the day-to-day of visits, billing, IRB renewals, and live inspection-readiness — non-captive, with full data export anytime.
Visit-window compliance
Protocol-window scheduling computes the earliest, target, and latest date for every visit and flags amber and overdue — before an out-of-window visit becomes a deviation.
Visit-to-invoice billing
Every completed visit becomes a billable line item against your CTA fee schedule, with an unbilled-revenue dashboard and AR aging — so no charge slips 30 days late.
IRB renewals & alerts
Continuing-review reminders at 30, 14, and 7 days before IRB expiration, with the renewal pre-filled from the parent approval — before a lapse becomes a finding.
Amendment impact analysis
When a protocol amends, AI flags the downstream site work — re-consent, retraining, Form 1572, IRB notification — as a clearly-marked draft for your review. AI never signs a regulated record.
Site compliance score
A GREEN / YELLOW / RED read on IRB status, deadlines, training, delegations, and open findings — the items an inspector surfaces, on your dashboard today.
Safety & quality tracking
Deviations, adverse events, and concomitant meds, plus training-log expiry and SOP version gating — the operational record a document binder doesn’t keep.
Nexrial runs alongside the binder you already use, never on top of it — open integrations, no captive lock-in, and your records export anytime, no exit fee.