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.
Built for modern clinical operations. Designed for speed.
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.
- 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:
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
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.
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

ePRO/eCOA

eConsent

Decentralized trial workflows

Workflow automation

Operational study configuration
This integrated approach helps reduce fragmented workflows and streamline study build activities across connected clinical systems.
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:
Importantly, 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
Why Captivate® AI Is Different
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.
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.
Flexible by Design
Captivate®'s configurable architecture supports diverse workflows across biotech, medical device, diagnostics, and decentralized studies.
Reusable Intelligence
Generated rules, forms, and workflows can be saved into reusable libraries to help improve consistency and accelerate future study builds.
Designed for Modern Clinical Operations
Captivate® AI supports sponsors, CROs, database programmers, clinical data managers, and study builders operating in fast-moving clinical environments.
Planned AI Innovations
Captivate®'s AI roadmap includes future initiatives focused on intelligent operational optimization and predictive workflow assistance.
Current AI Capabilities
AI-powered Rule Builder
Natural language rule generation
Cross-form query generation
Workflow automation assistance
Automated notification logic
Reusable expression libraries
Protocol-assisted eCRF generation
AI-generated event matrices
Suggested edit checks
Logic recommendations
Reusable AI-generated form libraries
AI-assisted workflow structuring
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.”
Frequently Asked Questions
What is AI-powered EDC?
Can Captivate® AI generate eCRFs?
Yes. Captivate® AI includes protocol-assisted workflows designed to help generate draft eCRFs and study structures that can then be reviewed and modified by study teams.
Can AI generate edit checks and validation rules?
Yes. Captivate® AI includes a natural language Rule Builder that helps users generate edit checks, workflow rules, automated notifications, and cross-form queries.
Does Captivate® AI replace clinical data managers?
No. Captivate® AI is designed to support clinical teams and reduce repetitive manual configuration work while maintaining human oversight.
Does Captivate® AI interact with PHI or PII?
Captivate® AI is designed for study build and workflow configuration activities and does not interact with patient PHI or PII within the AI workflow environment.
Can Captivate® AI automatically publish studies?
No. All AI-generated outputs remain draft recommendations that require human review and approval before deployment.
How does Captivate® AI improve study startup timelines?
AI-assisted workflows help reduce repetitive manual tasks associated with database build, edit check programming, workflow setup, and study 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.












