Captivate®. Accelerating Clinical Trials®

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Captivate® AI-Powered Clinical Trial Build

Accelerate study startup with AI-assisted protocol digitization, intelligent workflow automation, and natural language study configuration embedded directly into Captivate®.

Captivate® AI helps sponsors, CROs, and clinical data teams reduce repetitive build work, streamline study setup, and move from protocol to production faster while maintaining human oversight and regulatory alignment.

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Built for modern clinical operations. Designed for speed.

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Accelerate Clinical Trial Startup

Modern clinical trials are more complex than ever. Study teams are expected to build and launch studies faster while managing:

Captivate® AI is designed to help clinical teams accelerate study build workflows by reducing repetitive manual configuration tasks across the clinical trial lifecycle.

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  • Complex protocols
  • Global sites
  • Decentralized workflows
  • ePRO and eConsent integrations
  • Large volumes of edit checks and validation logic
  • Frequent protocol amendments
  • Increasing operational pressure

AI-Assisted Study Build

Transform protocols into structured study configurations faster. Captivate® AI helps streamline the creation of:

eCRFs
Event matrices
Visit schedules
Validation rules
Edit checks
Workflow logic
Automated notifications
Cross-form queries
Rather than manually configuring every study component from scratch, study teams can leverage AI-assisted workflow acceleration directly within Captivate® Build. Generated study structures remain fully reviewable, editable, and approval-driven.
AVAILABLE TODAY

Natural Language Rule Builder

Captivate® AI includes an embedded AI-powered Rule Builder that enables users to create complex edit checks and workflow logic using plain language prompts. Examples include:

  • Flag missing adverse event data
  • Trigger visit window notifications
  • Create protocol-driven screening logic
  • Compare values across forms or records
  • Generate PK and advanced calculation rules
Instead of manually building expressions through traditional rule editors or custom scripting, users can generate structured logic in seconds using natural language.
Key Benefits
Reduce repetitive rule programming
Accelerate database build timelines
Simplify complex logic creation
Improve operational efficiency
Support reusable rule libraries
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Protocol-to- Build Automation

Captivate® AI includes protocol-assisted study build capabilities designed to accelerate the transition from protocol to operational database design. Users can upload protocol documents into Captivate® Build to help generate:

  • Draft eCRFs
  • Visit schedules
  • Suggested edit checks
  • Structured event matrices
  • Study workflows
  • Logic recommendations

Generated study assets can then be reviewed, modified, approved, and saved into reusable libraries for future studies. The goal is not autonomous study creation. The goal is intelligent operational acceleration with human oversight.

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Embedded Intelligence Across the Captivate® Ecosystem

Captivate® AI is embedded directly into the Captivate® Build environment. Because Captivate® uses a unified build architecture across products, AI-assisted workflows can support:

EDC

EDC

ePRO-eCOA

ePRO/eCOA

eConsent

eConsent

Decentralized trial workflows

Decentralized trial workflows

Workflow automation

Workflow automation

Operational study configuration

Operational study configuration

This integrated approach helps reduce fragmented workflows and streamline study build activities across connected clinical systems.

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Designed for Human Oversight and Compliance

Captivate® AI is designed to support clinical teams, not replace them. All AI-generated workflows remain draft recommendations that require human review and approval before publication or deployment.

Captivate® AI:

Captivate® AI is designed specifically for study build and workflow configuration activities and does not interact with patient PHI or PII within the AI workflow environment. This architecture helps support operational governance, security, and compliance requirements for regulated clinical research.

  • Does not autonomously publish studies
  • Maintains human oversight workflows
  • Supports configurable review processes
  • Preserves auditability and traceability
  • Operates within controlled build environments
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Why Captivate® AI Is Different

1

Built Directly Into Clinical Trial Build Infrastructure

Captivate® AI is embedded inside the study build workflow itself rather than functioning as a disconnected external assistant.

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2

Focused on Operational Acceleration

Captivate® AI is designed to reduce manual build effort and compress study startup timelines from weeks or months toward days or hours for many workflows.

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3

Flexible by Design

Captivate®'s configurable architecture supports diverse workflows across biotech, medical device, diagnostics, and decentralized studies.

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4

Reusable Intelligence

Generated forms and workflows can be saved into reusable libraries to help improve consistency and accelerate future study builds.

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5

Designed for Modern Clinical Operations

Captivate® AI supports sponsors, CROs, database programmers, clinical data managers, and study builders operating in fast-moving clinical environments.

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FUTURE RELEASE

Planned AI Innovations

Captivate®'s AI roadmap includes future initiatives focused on intelligent operational optimization and predictive workflow assistance.

Planned Roadmap Areas
Workflow and study structure recommendations
Intelligent benchmarking insights
Predictive operational analytics
Advanced study simulation capabilities
Expanded protocol-to-build automation
Intelligent workflow orchestration
Reusable operational intelligence across studies

Current AI Capabilities

Available Today
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AI-powered Rule Builder

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Natural language rule generation

✓

Cross-form query generation

✓

Workflow automation assistance

✓

Automated notification logic

✓

Reusable expression libraries

In progress
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Protocol-assisted eCRF generation

✓

AI-generated event matrices

✓

Suggested edit checks

✓

Logic recommendations

✓

Reusable AI-generated form libraries

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AI-assisted workflow structuring

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Built for Faster Clinical Operations

Captivate® AI is designed to help:

Accelerate study startup

Reduce repetitive build tasks

Streamline UAT preparation

Improve operational efficiency

Reduce manual configuration burden

Support lean clinical operations teams

Improve CRO scalability

Increase workflow consistency across studies

“As clinical trials become increasingly digital, decentralized, and data-intensive, intelligent operational infrastructure becomes increasingly important.”

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Frequently Asked Questions

What is AI-powered EDC?
AI-powered EDC refers to Electronic Data Capture systems that use artificial intelligence and intelligent automation to accelerate workflows such as study build, edit check generation, and operational configuration.

Build Studies Faster with Captivate® AI

See how intelligent workflow automation can help your team accelerate study startup, streamline clinical operations, and reduce manual build effort across your clinical trial portfolio.

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