How does the 30-day free trial work?

Register your credit card to access all features for 30 days. No charge until the trial ends. Cancel anytime with no commitment.

Your data stays on your own infrastructure (on-premise or private cloud). We use SSL/TLS 256-bit encryption, comply with GDPR, and align with ISO 27001. We never access your operational data.

How long does implementation take?

Basic implementation takes 1-2 days. For enterprise deployments with custom integrations, typically 1-2 weeks. Configuration support is included in all plans.

Does it work without internet?

Yes. Certexi operates locally on your network. Offline mode allows full operation for up to 60 days without connectivity. Data syncs automatically when connection is restored.

Healthcare & Pharma

Clinical trial documentation that FDA inspectors and sponsors accept

Electronic records with complete audit trails, data integrity evidence, and GCP compliance documentation — deployed on-premise for full data sovereignty over trial data.

ich e6 gcpfda 21 cfr part 11eu clinical trials regulation

Start Free Trial Back to Healthcare & Pharma

30-day free trial · Private deployment included · Cancel anytime

The problem

Why existing approaches fail

×Site regulatory files maintained in binders with no version control or access audit trail
×Subject visit documentation not linked to protocol deviations and corrective actions
×FDA inspection preparation requires locating and organizing records across multiple file systems

The Certexi approach

Evidence generated at the point of work

Electronic regulatory binder with version control, access logging, and sealed document history
Protocol deviation workflow: detect → assess → document → correct → CAPA, all with audit trail
FDA inspection bundle: TMF organized by ICH E6 section, complete with audit trail evidence

Compliance coverage

Regulatory frameworks supported

Evidence generated by Certexi is designed to satisfy the requirements of these frameworks.

ICH E6 GCP FDA 21 CFR PART 11 EU CLINICAL TRIALS REGULATION

Related capabilities

Use cases that power this solution

document control audit preparation training records

PRECIOS

Alineado al Valor Operativo, No al Número de Usuarios

El precio depende del alcance del despliegue, no del número de usuarios. Tus datos. Tu infraestructura. Tus reglas.

Todos los planes incluyen despliegue privado. Tu información permanece en tu infraestructura.

ISO 27001 Aligned

Private Deployment

Unlimited Users

Piloto

Valida antes de comprometerte

Personalizado

5 lugares por trimestre

Despliegue completo de plataforma
Soporte de configuración
Capacitación e incorporación
Acceso directo al equipo de producto
Iteración basada en retroalimentación
Período de evaluación de 8 semanas

Estándar

Operaciones de una ubicación

Desde $2,500

por mes, facturado anualmente

Todas las capacidades centrales
Biblioteca de plantillas estándar
Despliegue privado incluido
Soporte por email (respuesta 24h)
Actualizaciones trimestrales
Usuarios ilimitados

Enterprise

Multi-ubicación, alto cumplimiento

Personalizado

Basado en alcance del despliegue

Todo lo de Estándar
Desarrollo de plantillas personalizadas
Ingeniero de soporte dedicado
Garantías SLA
Integraciones avanzadas
Opción de despliegue air-gapped

Despliegue Privado Incluido en Todos los Planes

Cada plan incluye despliegue completo en tu infraestructura — Nextcloud, servidores Linux, Docker, Kubernetes o entornos air-gapped. Tu información nunca sale de tu control.

On-Premise Deployment

Offline-First

ISO 27001 Ready

30-Day Free Trial

Ready to generate clinical trial documentation & gcp compliance evidence automatically?

GCP-compliant trial records with complete data integrity evidence.

Start Free Trial