AOClinical Trial Site Readiness AgentRunning on Agentic OS · CT-2026-301
Tony Choi
Clinical Operations Lead

Agentic OS Architecture

The Agentic OS is the reusable enterprise platform. The Clinical Trial Site Readiness Agent is one product built on top of it.

Layer 1

Clinical Enterprise Data

Clinical Trial Management SystemRegulatory Document RepositoryTraining Records (LMS)Enrollment Data (IWRS)Electronic Data Capture
↓
Layer 2

Secure Data Connectors

Read-only, permission-scoped access. PHI and unapproved datasets are filtered at the connector boundary.

↓
Layer 3 — reusable platform

Agentic OS

Identity & Access
Permissions
Data Retrieval
Agent Orchestration
LLM / Reasoning
Risk Evaluation
Human Approval
Action Execution
Audit & Traceability
Agent Evaluation
↓
Layer 4 — this product

Clinical Trial Site Readiness Agent

Retrieve → Analyze → Risk Assessment → Recommend → Prepare → Human Approval → Execute → Evaluate.

Future agents reusing the same platform

Enrollment Risk Agent

Forecasts recruitment shortfalls and rebalances site targets.

Reuses: identity, connectors, orchestration, approvals, audit
Regulatory Compliance Agent

Monitors essential document currency and inspection readiness.

Reuses: identity, connectors, orchestration, approvals, audit
Clinical Data Quality Agent

Detects query backlogs, deviations and data integrity signals.

Reuses: identity, connectors, orchestration, approvals, audit
Trial Operations Agent

Coordinates supply, monitoring visits and site payments.

Reuses: identity, connectors, orchestration, approvals, audit

Agent Registry

Manage, govern, and onboard agents running on the shared Agentic OS.

+ Onboard New Agent
Shared capabilities every registered agent reuses
✓ Identity & Access✓ Permissions Framework✓ Secure Data Connectors✓ Agent Orchestration✓ LLM Gateway✓ Human Approval✓ Audit & Traceability✓ Agent Evaluation Framework
Clinical Trial Site Readiness Agent
Active

Identifies clinical trial sites requiring attention and recommends operational actions.

Owner
Clinical Operations
Human approval
Required
Data connections
CTMSRegulatory RepositoryTraining RecordsEnrollment DataElectronic Data Capture
Capabilities
RetrieveAnalyzeRecommendPrepare Action
Evaluation
Site Readiness Eval v1.0
View Configuration
Enrollment Risk Agent
Planned

Forecasts recruitment shortfalls and identifies sites falling behind enrollment targets.

Owner
Clinical Operations
Human approval
Required
Data connections
Enrollment DataCTMS
Capabilities
RetrieveAnalyzeRecommend
Evaluation
To be defined
View Configuration
Regulatory Compliance Agent
Planned

Monitors regulatory documentation, compliance issues, and inspection readiness.

Owner
Regulatory Affairs
Human approval
Required
Data connections
Regulatory RepositoryCTMS
Capabilities
RetrieveAnalyzeRecommend
Evaluation
To be defined
View Configuration
Clinical Data Quality Agent
Planned

Identifies data query backlogs, deviations, missing data, and data integrity signals.

Owner
Data Management
Human approval
Required
Data connections
Electronic Data CaptureCTMS
Capabilities
RetrieveAnalyzeRecommend
Evaluation
To be defined
View Configuration
Trial Operations Agent
Planned

Coordinates operational activities such as monitoring visits, supply issues, and site payments.

Owner
Trial Management
Human approval
Required
Data connections
CTMSEnrollment Data
Capabilities
RetrieveAnalyzeRecommendPrepare Action
Evaluation
To be defined
View Configuration
  1. 1. Identify a high-value business problem
  2. 2. Build a focused agent
  3. 3. Identify reusable capabilities
  4. 4. Standardize them through Agentic OS
  5. 5. Register and govern agents
  6. 6. Onboard more agents without rebuilding
  7. 7. Continuously evaluate quality and outcomes