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
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Private deployment · Sovereign infrastructure · Architecture session included

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 GCPFDA 21 CFR PART 11EU CLINICAL TRIALS REGULATION

Related capabilities

Use cases that power this solution

document controlaudit preparationtraining records

PRICING

Aligned to Operational Value, Not User Count

Pricing scales with deployment scope, not headcount. Your data. Your infrastructure. Your rules.

All plans include private deployment. Your data never leaves your infrastructure.

ISO 27001 Aligned
Private Deployment
Unlimited Users
Currency

Pilot

Validate before you commit

Custom

5 spots per quarter

  • Full platform deployment
  • Configuration support
  • Onboarding and training
  • Direct product team access
  • Feedback-driven iteration
  • 8-week evaluation period

Standard

Single-location operations

From $4,800 / month

per month, billed annually

  • All core platform capabilities
  • Standard template library
  • Private deployment included
  • Email support (24h response)
  • Quarterly platform updates
  • Unlimited users

Enterprise

Multi-location, high-compliance

Custom

Based on deployment scope

  • Everything in Standard
  • Custom template development
  • Dedicated support engineer
  • SLA guarantees
  • Advanced integrations
  • Air-gapped deployment option

Private Deployment Included in All Plans

Every plan includes full deployment on your infrastructure — Nextcloud, Linux servers, Docker, Kubernetes, or air-gapped environments. Your data never leaves your control.

On-Premise Deployment
Offline-First
ISO 27001 Ready
Sovereign Deployment

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

GCP-compliant trial records with complete data integrity evidence.

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