Clinical operations,
precisely managed.
Stop managing your regulatory binder in shared folders and spreadsheet binders. Nexrial gives your research site one system for documents, delegation, deadlines, and audit trail — purpose-built for FDA inspection day.
Built for independent sites running 5–25 concurrent studies — the segment priced out of Veeva, OnCore, and Advarra.
Everything your site needs.
Nothing it doesn't.
Six core modules, one unified system. No plugins, no patchwork integrations.
Regulatory Binder
Centralized document management with version control, approval workflows, and PI e-signature integration. Track TMF completeness by study and section — so you know exactly where you stand before the monitor arrives.
Delegation Log
PI e-signature on delegation of authority, staff acknowledgment, re-sign workflows, and a complete audit trail. Every role assignment is timestamped and traceable — no paper logs, no after-the-fact reconstruction.
Complete Audit Trail
Tamper-evident, append-only log of every action — user, timestamp, IP, and field-level changes. Exportable for sponsor review or FDA submission. When the inspector asks, you hand it over in one click.
Deadline Tracking
Protocol milestones, IRB renewals, and sponsor deadlines with overdue alerts and daily email reminders. Never miss a compliance date. Deadlines surface on your dashboard and in your inbox before they become findings.
Multi-Site & Role Access
Separate access for PIs, coordinators, monitors, and sponsors. Each organization sees only their own data, scoped to their subdomain. CRAs get read-only access without coordinator involvement — every access event logged.
Subject Tracker & Visit Scheduling
Full subject lifecycle from screening through completion. Visit scheduling, enrollment tracking, adverse events, concomitant medications, and protocol deviations — all from one view across multiple active studies.
See what your team gets on day one.
Book a 20-minute demo and we'll walk you through a live instance configured for your site type.
Your command center for every active study
Enrollment counts, compliance status, document completeness, and deadline alerts — all on one screen. No toggling between tabs, no status update meetings to know where each study stands.
Every subject from screening through closeout
The full subject lifecycle managed in one place — fully auditable, without a single spreadsheet. Adverse events, concomitant medications, protocol deviations, and visit windows tracked in real time across all studies.
Spot scheduling gaps before they become findings
See scheduling density across all subjects and studies in a single calendar view. Identify visit clustering, overdue protocol windows, and open scheduling gaps at a glance — before a monitor does.
Every action logged. No gaps. No reconstruction.
Every user action recorded automatically with user identity, timestamp, IP address, and field-level change data. When the monitor or FDA asks, you export and hand it over. That's it.
See all four views in a live 20-minute session — configured for your site type before the call ends.
Book a demoYour site is live in one session,
not one quarter.
Set up your site
Add your studies, team members, and PI credentials. Nexrial creates your regulatory structure automatically — no IT department required.
Run your operations
Track documents, deadlines, delegation, and subject enrollment from one dashboard. No spreadsheet sprawl. No shared-folder archaeology.
Stay audit-ready
Every action is logged. Every signature is timestamped. When the monitor walks in, you're already prepared — not scrambling to reconstruct.
Straightforward. No seat fees.
One flat monthly rate per research site. Add your entire team without watching the invoice climb.
Nexrial costs less than a single missed visit invoice. Most sites recover the annual cost in the first month.
Built for the segment the enterprise CTMS market skipped.
Comparison is structural, not feature-for-feature. Enterprise products serve sponsors and CROs; Nexrial is built for the site.
Limited to the first five sites. After the cap, pricing reverts to Core.
Built by clinical research coordinators, for clinical research sites. Save 18% with annual prepay.
Many sponsors reimburse sites for CTMS costs — we provide documentation to include Nexrial in your study budget.
Common questions
Is there a free trial?
We don't offer self-serve trials. Every new site starts with a guided demo where we configure a working instance for your site. Book a demo and see your own workflow in action.
How long does setup take?
Most sites are fully operational within one session. We set up your studies, users, and binder structure with you — live in one session, not one quarter.
What happens if I cancel?
Your data is always exportable. Documents, audit trail, and subject records can be exported at any time. We retain your data for 90 days after cancellation for compliance purposes.
Does Nexrial implement 21 CFR Part 11 controls?
Nexrial implements the controls of 21 CFR Part 11: a tamper-evident, append-only audit trail recording every action with user identity, timestamp, and IP address, plus electronic signatures with signature meaning captured at signing. Part 11 is a design standard, not a certification — Nexrial ships the controls; your organization is responsible for validated use and your own SOPs. A full IQ/OQ/PQ validation package (11 documents) is available on request.
How is patient data protected?
All PHI is encrypted at rest using AES-256-GCM and in transit via TLS. Access is controlled through role-based permissions scoped to each organization. A signed HIPAA Business Associate Agreement is in place before any data enters the system. We do not sell, share, or use your data for any purpose other than running your site.
Can my CRA or sponsor monitor access documents remotely?
Yes. You can grant monitors read-only access to your regulatory binder, audit trail, and study documents. They see exactly what they need for source verification without requiring coordinator time to pull files. Access is logged in the audit trail.
Do I need IT support to run Nexrial?
No. Nexrial is fully cloud-hosted — there is nothing to install, no servers to maintain, and no IT department required. Your team accesses it through a web browser. We handle all updates, backups, and security patches.
Can sponsors reimburse the cost?
Many sponsors include CTMS costs as a reimbursable site expense in the Clinical Trial Agreement. We provide documentation to help you include Nexrial in your study budget during CTA negotiation.
What if I already use another system for my regulatory binder?
Nexrial works alongside existing tools. If your sponsor requires a specific eISF or document platform, Nexrial handles the operational side — visit scheduling, subject tracking, delegation logs, and audit trail — that those systems typically do not cover. Many sites use Nexrial for clinical operations and a separate tool for sponsor-mandated document filing.
Ready to replace
the spreadsheet binder?
Book a 20-minute demo with the team that built Nexrial — we'll show you a live instance and configure a trial for your site on the spot. Demos run on a staged instance seeded with your schedule-of-assessments. You drive the session.