Captivate®. Accelerating Clinical Trials®

⎯⎯⎯ Captivate EDC

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Seamlessly Capture Data

Electronic data capture with no-code form building, real-time dashboards, and advanced branching logic. Power your study with precision and speed.

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EDC Built for
Modern Clinical Teams
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.

Scale with Flexibility

Built for studies ranging from small pilots to complex global programs, it combines intuitive, no‑code study build tools with advanced customization. Teams can configure quickly and scale without re‑platforming.

Compliance & Speed

Pre-validated and compliant out of the box, Captivate EDC helps teams reduce startup timelines and maintain inspection readiness from day one, allowing you to focus on the study, not the infrastructure.

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Build
Studies Your Way
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.
1

Drag‑and‑Drop Design

Create CRF and visit design with conditional logic, validations, and calculations without code.

2

Complex Workflows

Support for complex workflows, adaptive designs, and sub‑studies when you need them.

3

Reusable Components

Forms, visit schedules, and libraries to standardize across your programs.

4

Optional JavaScript

Advanced functionality such as clickable images, task‑timing clocks, QR scanning, and custom logic.

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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 go‑live.

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

Reduced Documentation

Less 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

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

Auditability across all 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

Enrollment, data completeness, and study health visibility

Query Management

Configurable workflows for efficient query resolution

Role‑Based Views

Tailored interfaces for sites, monitors, sponsors, and data managers

Automated Alerts

Reminders to reduce manual follow‑up work

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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 whenever you need it.

Configurable Exports

Exports including SAS‑ready datasets for analysis.

Comprehensive Audit Trails

Complete tracking 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.

21 CFR Part 11, Annex 11, GDPR, and HIPAA compliance

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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Built for Compliance And
Inspection Readiness
Designed to support regulated clinical research environments and global compliance expectations.
1

More Flexible & Faster

More flexible and faster to configure than legacy systems that require heavy services and long startup timelines.

2

More Powerful & Scalable

More powerful and scalable than lightweight EDCs that lack advanced logic, auditability, or performance.

3

Grows Without Migration

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

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Who Uses Captivate EDC
Used by sponsors, CROs, academic institutions, diagnostics companies, and medical device organizations running interventional trials and registries.
Phase I-IV Trials
Post‑Market Studies
Registries
Multi‑Study Programs
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Why Data Management
Teams Choose Captivate
1

Faster Study Builds

Without sacrificing flexibility

2

Intuitive Tools

Reduces reliance on programming

3

Advanced Customization

When you need it

4

Continuous Readiness

Inspection readiness from day one

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.

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