⎯⎯⎯ Captivate EDC

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Captivate®
EDC

Flexible, Pre-Validated Electronic Data Capture Built for RealWorld Clinical Trials

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Product Overview

Configure faster, stay inspection-ready, and scale seamlessly with a pre-validated EDC designed for studies of any size.

Enterprise-Grade EDC

Captivate EDC is a modern, enterprise-grade Electronic Data Capture system designed for clinical data managers who need flexibility, control, and speed without the overhead of rigid, expensive platforms or the limitations of lightweight tools.

Scale with Flexibility

Built for studies ranging from small, fast-moving pilots to complex global programs, Captivate EDC combines intuitive, no-code study build tools with advanced optional customization and powerful livestudy capabilities.

Compliance & Speed

Captivate EDC is pre-validated and compliant out of the box, helping teams reduce startup timelines and focus on running the study, not managing infrastructure or validation burden.

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Build
Studies Your Way

Captivate EDC is designed to support how data managers actually build and manage studies, balancing ease of use with advanced configurability.

1

Drag‑and‑Drop Design

Drag-and-drop CRF and visit design with conditional logic, validations, and calculations

2

Complex Workflows

Support for complex workflows, adaptive designs, and sub-studies

3

Reusable Components

Reusable forms, visit schedules, and libraries to standardize across programs

4

Optional JavaScript

Optional JavaScript support for advanced functionality

5

Full Audit Trails

Full audit trails for all configuration and build changes

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No-Code by Default.
Advanced When You Need It

Most Captivate customers build studies using intuitive, drag-and-drop tools without writing code.

For more advanced use cases, Captivate also supports optional scripting and custom functions, giving experienced teams additional flexibility without forcing complexity on everyone.

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Faster Study Startup with Pre‑Validation

Captivate EDC is pre-validated, meaning the core system has already undergone validation by our team. This significantly reduces the effort required by sponsors and CROs and accelerates time to golive.

Four Week Build Time

Average study build time of approximately four weeks

Fast Track Available

Some simple studies live in as little as 24 hours

Study-Specific UAT Only

No need to perform full system validation, only study-specific UAT

Reduced Documentation

Reduced documentation burden while maintaining inspection readiness

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Seamless Data Flow Across
Your Clinical Ecosystem

Captivate EDC is designed to sit at the center of your clinical data stack, supporting clean, controlled data flow across  systems and vendors.

1

Native VDC Integration

Native integration with Captivate VDC modules such as ePRO and eConsent

2

Secure Bulk Imports

Secure bulk imports via SFTP for labs and external data sources

3

Configurable Exports

Configurable datasets for downstream analysis and reporting

4

Consistent Audit Trail

Consistent audit-ability across integrated data sources

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Run Live
Studies With Confidence

Once a study is live, Captivate EDC provides real-time visibility into study progress and data quality, enabling proactive monitoring and faster issue resolution.

Real‑Time Dashboards

Real-time dashboards showing enrollment, data completeness, and study health

Query Management

Query management with configurable workflows

Role‑Based Views

Role-based views for sites, monitors, sponsors, and data managers

Automated Alerts

Automated alerts and reminders to reduce manual follow-up

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Data Quality, Exports
And Inspection Readiness

Captivate EDC maintains continuous traceability from first data entry through database lock.

Real‑Time Clean Data

Real-time access to current, clean data

Configurable Exports

Configurable exports including SAS-ready datasets

Comprehensive Audit Trails

Comprehensive audit trails for subjects, users, roles, and data changes

Database Lock & Closeout

Structured workflows for database lock and study closeout

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Security, Compliance And Control

Captivate EDC is compliant out of the box with global regulatory and privacy requirements and is designed to support audits and inspections without disruption.

Compliance with 21 CFR Part 11, Annex 11, GDPR, and HIPAA

Built-in PHI and PII masking features

Role-based access controls and authentication

Detailed audit trails for data, users, and permissions

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A Smarter Alternative to
Traditional EDCs

Captivate EDC was built to avoid the tradeoffs teams often face when choosing between rigid
enterprise platforms and limited low-cost tools.

1

More Flexible & Faster

More flexible and faster to configure than legacy systems

2

More Powerful & Scalable

More powerful and scalable than lightweight EDCs

3

Grows Without Migration

Designed to grow with your pipeline without forcing migrations or disruptive upgrades

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Who Uses Captivate EDC

Captivate EDC is used by sponsors, CROs, academic institutions, diagnostics companies, and medical
device organizations running interventional trials and registries.

Phase I–IV clinical trials
Post-market and observational studies
Disease and product registries
Multi-study programs requiring reuse and standardization
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Why Data Management
Teams Choose Captivate
1

Faster Study Builds

Faster study builds without sacrificing flexibility

2

Intuitive Tools

Intuitive tools that reduce reliance on programming

3

Advanced Customization

Advanced customization when needed

4

Continuous Readiness

Continuous inspection readiness

5

Expert Support

Responsive support from clinical data experts

6

Pre‑Validated

Compliant out of the box

Ready to Learn More?

Discover how Captivate can support your clinical research needs. Our team is here to answer questions and show you what’s possible.