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Layered Clinical Architecture

Layered capability model showing personas, hub modules, AI augmentation, analytics, data, integration fabric, and source systems. This workspace exists to enforce consistent clinical execution with accountable ownership, governed evidence, and inspection-ready traceability across the study lifecycle. It supports business and regulatory requirements by connecting operations, quality, submissions, and financial controls in a single system where handoffs are explicit and auditable. Users can proceed by filtering scope, reviewing linked artifacts and actions, and routing escalations with defined approval gates and signature meaning.

Layered Architecture

Operating layers from personas to source systems with governed data and evidence flow.

Users / Personas Layer
Clinical Ops

Connected to governed workflows and traceable evidence.

SSU

Connected to governed workflows and traceable evidence.

CRA/CTM

Connected to governed workflows and traceable evidence.

Data Mgmt

Connected to governed workflows and traceable evidence.

Biostats

Connected to governed workflows and traceable evidence.

Safety

Connected to governed workflows and traceable evidence.

Quality

Connected to governed workflows and traceable evidence.

Regulatory

Connected to governed workflows and traceable evidence.

Supply/IRT

Connected to governed workflows and traceable evidence.

Vendor Mgmt

Connected to governed workflows and traceable evidence.

Finance

Connected to governed workflows and traceable evidence.

IT/Sec

Connected to governed workflows and traceable evidence.

External Collaborators

Connected to governed workflows and traceable evidence.

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Application / Consumption Layer
Clinical Development Hub

Connected to governed workflows and traceable evidence.

↓
Clinical Hub Capabilities Layer
SSU

Connected to governed workflows and traceable evidence.

CTMS Ops

Connected to governed workflows and traceable evidence.

TMF

Connected to governed workflows and traceable evidence.

RBQM

Connected to governed workflows and traceable evidence.

Data Ops

Connected to governed workflows and traceable evidence.

Safety

Connected to governed workflows and traceable evidence.

Supply

Connected to governed workflows and traceable evidence.

Regulatory/CTIS

Connected to governed workflows and traceable evidence.

Vendors

Connected to governed workflows and traceable evidence.

Finance

Connected to governed workflows and traceable evidence.

Training

Connected to governed workflows and traceable evidence.

Security

Connected to governed workflows and traceable evidence.

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Generative AI Layer
Assistant

Connected to governed workflows and traceable evidence.

Constrained Agents

Connected to governed workflows and traceable evidence.

Approval Gate

Connected to governed workflows and traceable evidence.

Evidence Routing

Connected to governed workflows and traceable evidence.

↓
Analytics & Monitoring Layer
Dashboards

Connected to governed workflows and traceable evidence.

KRIs

Connected to governed workflows and traceable evidence.

Risk Scoring

Connected to governed workflows and traceable evidence.

SLA Heatmaps

Connected to governed workflows and traceable evidence.

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Data + Document Layer
Master Study/Site Model

Connected to governed workflows and traceable evidence.

TMF Metadata

Connected to governed workflows and traceable evidence.

EDC Extracts

Connected to governed workflows and traceable evidence.

Operational IDs

Connected to governed workflows and traceable evidence.

↓
Integration Fabric Layer
API Gateway

Connected to governed workflows and traceable evidence.

Event Bus

Connected to governed workflows and traceable evidence.

Connectors

Connected to governed workflows and traceable evidence.

Mapping Rules

Connected to governed workflows and traceable evidence.

↓
Systems & Source Layer
CTMS

Connected to governed workflows and traceable evidence.

eTMF

Connected to governed workflows and traceable evidence.

EDC

Connected to governed workflows and traceable evidence.

eCOA/ePRO/eConsent

Connected to governed workflows and traceable evidence.

RTSM/IRT

Connected to governed workflows and traceable evidence.

Labs

Connected to governed workflows and traceable evidence.

Imaging

Connected to governed workflows and traceable evidence.

ECG

Connected to governed workflows and traceable evidence.

Safety/PV

Connected to governed workflows and traceable evidence.

Submissions + CTIS

Connected to governed workflows and traceable evidence.

QMS

Connected to governed workflows and traceable evidence.

Finance/ERP

Connected to governed workflows and traceable evidence.

IAM/SSO

Connected to governed workflows and traceable evidence.

Collaboration

Connected to governed workflows and traceable evidence.

CRO/CDMO feeds

Connected to governed workflows and traceable evidence.

Data lake/warehouse

Connected to governed workflows and traceable evidence.

Cloud storage

Connected to governed workflows and traceable evidence.

Access & Governance Controls
RBAC+ABACStudy Firewall Active

Operational Controls

Study firewalling chips highlight boundary, country constraints, and vendor partition rules.

Actions requiring GxP control include a human review checkpoint and e-signature meaning capture.

Every state change writes immutable audit evidence with actor, timestamp, and object reference.

Next Actions

Filter to portfolio/program/study context.

Open linked tasks, risks, and document evidence.

Escalate blocked items through governed workflow.