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X7InsightEDC for clinical research

A complete EDC for the entire clinical-data lifecycle — from entry to database lock: immutable audit, electronic signatures, access control.

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Designed for 21 CFR Part 11, EU GMP Annex 11 and ICH E6.

The record spine

Every record’s journey — always visible

Four status axes — entry, verification, signature, lock — read at a glance: from a single eCRF field to the whole-study matrix.

RU-001-003 · Visit 1 · Vital Signs
Systolic BP128mmHg
Entry
data captured
completion
Verification
SDV complete
sdv
Signature
investigator e-signature
signed
Lock
awaiting database lock
locked

The axes are orthogonal, not wizard steps: a signature does not require SDV, and editing a signed value invalidates it. Status is derived from coverage, never toggled by hand.

ALCOA++

Every action lands in an immutable journal

Hash-chain audit records who, what and when — a traceless edit is technically impossible.

Capabilities

Everything a clean database needs

The core covers the regulatory requirements, and the status of every record is visible at a glance — from an eCRF field to the whole-study matrix.

Part 11 e-signatures

Meaning, coverage and a data snapshot are fixed at signing time. Any later edit of the covered data automatically invalidates the signature.

Hash-chain audit · ALCOA++

An immutable audit trail with a cryptographic chain: every change records who, when and why — with verifiable integrity.

Risk-based SDV

Source data verification driven by risk: full, targeted or sampled. Progress is visible from a single field to the entire study.

Blinding & masking

Blinded values are masked by the server, not the UI: a role without clearance never receives the value — not in the API, not in exports.

Policy-based access (PBAC)

Permissions derive from policies over the scope hierarchy: study → site → subject → form. Every denial is explainable.

Extensible by modules

The core is a complete EDC on its own. Optional modules — design authoring, medical coding, format exporters — extend it without touching the validated core.

Standards

Compliance & data standards

  • 21 CFR Part 11
  • EU GMP Annex 11
  • ICH E6 GCP
  • ALCOA++
  • CDISC ODM
  • Dataset-JSON

The data model aligns to CDISC (ODM, Dataset-JSON) and SDTM/CDASH; the audit trail, e-signatures and access control are designed for 21 CFR Part 11 and EU GMP Annex 11.

Ready for a clean database?

Sign in and walk a record through the full lifecycle: entry, query, verification, signature, export.

Enter the platform

Questions & onboarding — info@x7insight.ru