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.
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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.
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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.
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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.
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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.