CDM Integrity Systems — Clinical Data Management

CDM SENTINEL

From compliance statements to compliance evidence.

The transversal governance, risk, control, compliance and evidence layer of the CDM ecosystem.

CDM / CDM SENTINEL

Integrity Systems operates the research. Sentinel proves its integrity.

CONTENT ARCHITECTURE

Continue your CDM evaluation.

Select an area to review its purpose, operating model, boundaries and required evidence.

HOW IT CONNECTS

Each domain preserves context, accountability and evidence throughout the research lifecycle.

01

Governance

Versioned frameworks, requirements, controls, ownership and review cycles.

02

Risk & Quality

Risks, findings, CAPA, assessments and accountable follow-up.

03

Evidence

Automatic and documentary evidence with provenance, timestamps and integrity attributes.

04

Audit Readiness

Traceable packages, manifests and status explanations designed to support review.

CLAIMS BOUNDARIES

Public information separates design, confirmed scope, implementation status and approved evidence. No unsupported certification or capability is presented.

Sentinel reports readiness, evidence and gaps. It does not guarantee certification, legal compliance, FDA approval or EMA acceptance.