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Study Intelligence Agentic AI Protocol to Report

Study Intelligence Agent

The Study Intelligence Agent orchestrates post-contract research delivery from protocol design to execution monitoring, insight intervention, report generation, and compliance assurance. Five specialized agents work as one closed-loop system to keep studies fast, reliable, and audit-ready.

Business Scenario Architecture View

Five Core Agents

Cover the full study lifecycle with speed, quality, and compliance in sync.

Protocol Builder Drafts and aligns protocols.
Study Execution Sentinel Breaks down and tracks tasks.
Study Insights Engine Monitors data and guides decisions.
Report Generation Agent Analyzes and delivers reports.
QA & Compliance Agent Enforces SOP and auditability.

Business Scenario and AI Agent Connection

After a contract is signed, the Study Director must balance timelines, models, resources, and compliance. The Study Intelligence Agent breaks the journey into five coordinated roles so protocol creation, execution monitoring, insight intervention, report delivery, and compliance validation stay connected in a closed loop.

Protocol Generation Pulls quote details on models, mice, and reagents, plus historical efficacy programs, to create a protocol draft for rapid client alignment.
Execution Breakdown Translates the protocol into executable tasks (dosing, inoculation, sampling) and tracks milestones against contract terms.
Insight Intervention The Study Insights Engine watches data signals during execution and triggers alerts or decision support when deviations appear.
Report Delivery At project close, automatically consolidates data, generates charts, and completes the final customer report.

1. Protocol Builder

Starts after signature to draft protocols using historical models and study patterns.

2. Study Execution Sentinel + Study Insights Engine

Breaks down tasks and monitors live data to keep execution on track.

3. Report Generation Agent

Collects outcomes and produces the final report with structured analysis.

4. QA & Compliance Agent

Enforces SOP alignment and audit readiness across every agent.

Study Intelligence Agent Architecture

The architecture restores the interactive layout, groups blocks by function, and deepens the report generation area into data mart, visualization, and delivery packaging. The Data Layer stays to the left of Insights, while Tools occupy the right-side lane.

Unified view across personas, orchestration, agent pods, and data foundations.

Engagement + Orchestration Agent Pods Data Layer Tools Layer Persona Workspaces Study Director, QA, PM CRM, Portal, Collaboration Study Intelligence Orchestrator Planner, Tool Router, Memory Graph Multi-agent execution and feedback loops Governance Control Plane SOP policy, audit lineage Risk overrides and approvals Protocol Builder Quote to protocol draft Study precedent reuse Execution Sentinel Task graph, SLA tracking Resource coordination Insights Engine Signal monitoring Decision recommendations Report Generation Agent Narrative assembly, chart automation QA gating and sponsor delivery Regulatory packaging, citations QA & Compliance SOP guardrails Audit kits Knowledge Fabric Protocols, SOPs, literature Operational Spine LIMS, ELN, inventory Insights Data Lake Metrics, telemetry, trends Report Data Mart Curated datasets Visualization Studio Charts, figures, imagery Delivery & Templates Client formats, submission Packaging and approvals

Deep Dive: Five Agent Capabilities

Protocol Builder

From quote inputs to protocol draft, enabling rapid SD and client co-authoring.

Core Responsibilities

  • Leverage similar studies to generate protocol structure.
  • Auto-fill study design, dosing, and endpoints.
  • Capture revisions with full traceability.

Key Capabilities

  • Template-based protocol blocks.
  • Explainable precedent references.
  • Collaborative review and approvals.

Business Impact

  • Shorter protocol cycles.
  • Fewer omissions and deviations.
  • Higher client confidence.

Study Execution Sentinel

Turns protocols into executable task graphs and ensures milestones stay on track.

Core Responsibilities

  • Generate dosing, inoculation, sampling task plans.
  • Monitor resources, staff, and model status.
  • Trigger escalation on delays or deviations.

Key Capabilities

  • Dependency-aware scheduling.
  • Integration with LIMS, ELN, inventory.
  • SLA tracking dashboards.

Business Impact

  • Less rework and waiting time.
  • Higher resource utilization.
  • Stable execution cadence.

Study Insights Engine

Analyzes live data signals to deliver alerts and decision support.

Core Responsibilities

  • Track critical metrics and anomaly trends.
  • Push intervention recommendations.
  • Feed insights back to execution tasks.

Key Capabilities

  • Streaming data monitoring.
  • Model-driven alert rules.
  • Closed-loop decision logging.

Business Impact

  • Reduced risk during execution.
  • Stronger SD control of study status.
  • Higher-quality report insights.

Report Generation Agent

Auto-collects, analyzes, and visualizes data to deliver client-ready reports.

Core Responsibilities

  • Aggregate data, images, and review notes.
  • Generate charts and executive summaries.
  • Format output to client templates.

Key Capabilities

  • Template-driven report assembly.
  • Traceable data citation.
  • Version control and approvals.

Business Impact

  • Delivery in days, not weeks.
  • Consistent report quality.
  • Improved client delivery experience.

QA & Compliance Agent

End-to-end compliance guardrails to enforce SOP and audit readiness.

Core Responsibilities

  • Validate SOP compliance for protocols and reports.
  • Detect deviations or missing evidence.
  • Prepare audit-ready documentation.

Key Capabilities

  • Policy engines and compliance rules.
  • Audit trails and risk scoring.
  • Mandatory approvals and alerts.

Business Impact

  • Lower compliance risk.
  • Fully traceable deliverables.
  • Stronger study credibility.