⎯⎯⎯  Captivate Coder

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Captivate®
Coder

Integrated, Accurate Medical Coding for Clinical Studies 

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Product Overview
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 audit-ability throughout the coding lifecycle.

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Flexible, Standards-Aligned
Coding Workflows

Captivate Coder supports systematic application of medical dictionaries to clinical terms captured in EDC and other sources, while enabling teams to define rules that align with their operational and quality expectations.

01

Global Dictionary Support

Support for widely adopted medical dictionaries including MedDRA, WHO-Drug, ICD, and CTCAE

02

Configurable Versions

Configurable dictionary versions based on study requirements.

03

Comprehensive Mapping

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

04

Hierarchical Structures

Support for hierarchical term structures to preserve context and consistenc.

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Intelligent Automation And Human Review

Captivate Coder balances automated suggestions with structured human review to support both efficiency and accuracy. 

Automated Suggestions

Automated suggestion of coded terms for review

Pattern Matching

Dictionary-aware pattern matching to improve first-pass accuracy

Custom Coding Rules

Support for custom coding rules to surface preferred term su

Real-Time Feedback

Real-time feedback loops for coding specialists during review

Automation is configurable, enabling teams to adjust the balance of machine-assisted suggestions and manual control to match their quality requirements.

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Controlled Review And Quality Oversight

Captivate Coder supports structured review and adjudication to maintain coding integrity and traceability throughout the study lifecycle.

1

Role-Based Workflows

Role-based review and approval workflows .

2

Version History

Version history and change tracking for coded terms.

3

Adjudication Support

Commenting and rationale capture to support adjudication.

4

Searchable Audit Trails

Searchable audit trails tied to coding activities.

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Seamless Integration With Captivate EDC

Captivate Coder is integrated with the Captivate EDC environment, enabling teams to manage clinical data and coded terms within a unified ecosystem.

Direct CRF Access

Direct access to CRF terms requiring coding without data export

Shared Context

Shared subject and event context between clinical entries and coded outputs

Unified Reporting

Unified reporting that includes both source and coded data

Analysis Readiness

Simplified exports for analysis and regulatory submission readiness

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A Practical Alternative to Standalone
Coding Tools

Captivate Coder delivers robust, standards-aligned medical coding without requiring standalone software or disruptive integrations.

More Integrated

More integrated than disconnected coding spreadsheets or manual workflows.

More Structured

BMore structured and traceable than point solutions lacking audit and dictionary management.

Supports Any Study

Designed to support studies of varying size and complexity without unnecessary overhead.

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Security, Compliance And Traceability

Captivate Coder is designed to meet regulatory expectations and support disciplined quality processes without unnecessary complexity.

Compliance with 21 CFR Part 11, Annex 11, GDPR, and applicable privacy standards

Secure, role-based system access tied to study permissions

Detailed audit trails for coding decisions and workflows

Configurable dictionary versioning to support transparency across coding activities

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Who Uses Captivate Coder

Captivate Coder is used by study sponsors, CROs, and clinical data management teams who need consistent, efficient medical coding to support clinical data review and analysis.

Coding adverse events across Phase I–IV studies
Standardizing concomitant medications and medical history entries
Supporting pooled safety analyses across programs
Preparing coded outputs for regulatory submissions and safety reporting
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Why Study Teams Choose
Captivate Coder
1

Standards-Aligned

Standards-aligned application of medical dictionaries

2

Balanced Automation

Balanced automation with controlled human review

3

Integrated Workflows

Integrated workflows with Captivate EDC

4

Traceable Histories

Traceable review and audit histories for quality oversight

5

Configurable Rules

Configurable dictionary versions and coding rules 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.