Your clinical trial data
lives in 14 systems.
Your auditors need one.
HIPAA, GxP, 21 CFR Part 11. Regulatory frameworks demand end-to-end traceability. But the distance between your clinical protocol and the production database that stores patient data is filled with undocumented middleware and manual handoffs. Coherence closes that gap.
The Problem
Compliance is not a layer. It is the architecture.
Pharma organizations treat compliance as a documentation exercise layered on top of systems. The result: audit seasons require weeks of manual evidence gathering, regulatory changes take months to propagate, and nobody can prove that the CRF data in the EDC system actually maps to the protocol definition.
| Before Coherence | After Coherence |
|---|---|
| Manual GxP evidence gathering (weeks) | Continuous compliance evidence from the ontology (seconds) |
| "We think this data maps to that protocol" | "This field is governed by Protocol §4.2.1, linked to CRF Form 7" |
| Regulatory changes require manual impact analysis | Blast radius computed before the regulation is published |
| Patient consent policies documented in PDFs | Consent policies encoded as formal governance rules in the graph |
End-to-End Lineage
From clinical protocol to database column.
Ingest your regulatory documents, clinical protocols, EDC schemas, and production databases. The ontology links them structurally — not through metadata tags, but through typed relationships with confidence scores and provenance.
Protocol → CRF → Database
Every clinical data field traced from the protocol definition through the case report form to the physical database column.
Patient Consent Encoding
Consent policies become formal governance rules. Data access automatically scoped to consent boundaries.
Regulatory Change Propagation
When a regulation changes, the Transformation Map shows every affected system, process, and data flow.
Audit-Ready Evidence
Every graph node carries provenance, confidence scores, and human curation history. Export audit packages on demand.
Structural Compliance
HIPAA is not a document. It is a graph constraint.
Encode regulatory requirements directly into the ontology as formal rules. Every regulation requires a control. Every control requires an implementation. Every implementation is traced to source code. Gaps are surfaced automatically and assigned to human stewards for remediation.
Example compliance queries
"Show me every system that processes PHI without a documented consent policy."
"Which clinical trial data flows lack end-to-end encryption validation?"
"Prove that our adverse event reporting meets 21 CFR Part 11 requirements."
"What is the blast radius of this FDA guidance change on our production systems?"
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