Captivate®. Accelerating Clinical Trials®

⎯⎯⎯  Captivate Coder

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Effortless Medical Coding
Integrated, Accurate Medical Coding for Clinical Studies
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Integrated Medical Coding
for Clinical Trials
Streamline coding of adverse events, medications, and medical history with structured, audit-ready workflows.

Standardized Medical Coding

Captivate Coder is a flexible, integrated medical coding solution designed to help sponsors, CROs, and clinical data managers standardize adverse events, concomitant medications, and medical history terms using recognized medical dictionaries.

Seamless Platform Integration

Built to work within the Captivate clinical data platform, Captivate Coder provides structured, traceable, and compliant coding workflows that support data quality, analysis readiness, and regulatory expectations.

Automated Efficiency & Quality

By combining intuitive workflows with configurable automation and quality controls, Captivate Coder helps teams reduce manual effort, improve consistency, and maintain full auditability throughout the coding lifecycle.

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Flexible, Standards-Aligned
Coding
Systematic application of medical dictionaries to clinical terms. Standardize mappings to industry-recognized dictionaries for downstream analysis.
01

Global Dictionary Support

Widely adopted dictionaries including MedDRA, WHO-Drug, ICD, and CTCAE.

02

Configurable Versions

Dictionary versions based on study requirements to support diverse protocols.

03

Comprehensive Mapping

Term mapping for adverse events, medications, medical history, and coded fields.

04

Hierarchical Structures

Support for hierarchical term structures to preserve critical context and consistency.

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Intelligent Automation And Human Review

Balance automated suggestions with structured human review to support both efficiency and accuracy. Reduce manual effort while improving consistency.

Automated Suggestions

Initial proposals based on dictionary matches and term patterns

Pattern Matching

Dictionary-aware pattern matching to improve first-pass accuracy

Custom Coding Rules

Rule-based suggestions to surface preferred term mapping

Real-Time Feedback

Continuous feedback loops for coding specialists during review

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Controlled Review And Quality Oversight
Maintain coding integrity and traceability through structured review and adjudication throughout the study lifecycle.
1

Role-Based Workflows

Secure review and approval workflows tied to specific study permissions.

2

Version History

Complete tracking for coded terms and change history for every decision.

3

Adjudication Support

Commenting and rationale capture to support thorough coding adjudication.

4

Searchable Audit Trails

Fully traceable logs tied to all coding activities and decisions.

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Seamless Integration With Captivate EDC

Manage clinical data and coded terms within a unified ecosystem. Eliminate translation gaps and support analysis quality.

Direct CRF Access

Code CRF terms directly without the need for data export

Shared Context

Shared subject and event context between clinical and coded data

Unified Reporting

Dashboards that include both source and coded clinical data

Analysis Readiness

Simplified exports for regulatory submission readiness

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A Practical Alternative
Robust, standards-aligned medical coding without requiring standalone software or disruptive integrations.

More Integrated

No more disconnected coding spreadsheets or manual workflows.

More Structured

Better traceability than point solutions that lack audit trails.

Supports Any Study

Designed to support studies of varying size and complexity.

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Security, Compliance And Traceability

Designed to meet regulatory expectations and support disciplined quality processes without unnecessary complexity.

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

Secure, role-based system access tied to permissions

Detailed audit trails for coding decisions and workflows

Configurable dictionary versioning for transparency

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Who Uses Captivate Coder
Used by sponsors, CROs, and data management teams requiring consistent, efficient medical coding for clinical data review.
Phase I–IV Studies
Safety Analyses
Regulatory Submissions
Medical History Entries
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Why Study Teams
Choose Captivate
1

Standards-Aligned

Application of global medical dictionaries

2

Balanced Automation

Assisted coding with controlled human review

3

Integrated Workflows

Unified directly with Captivate EDC

4

Traceable Histories

Full audit trails for quality oversight

5

Configurable Rules

Dictionary versions to support diverse protocols

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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