TrialKit Coder

TrialKit Coder is a medical coding solution from Crucial Data Solutions designed for clinical trial teams who need to identify, code, and manage clinical data with accuracy and consistency. By mapping EDC entries to standardized medical dictionaries in near real time, TrialKit Coder helps ensure that adverse events, concomitant medications, and patient histories are interpreted reliably across sites and participants — supporting better data quality and faster regulatory approval.

As the first native mobile app to support both WHODrug and MedDRA dictionaries, TrialKit Coder is available as a web application and a mobile app, giving study teams the flexibility to code from any device. Its intuitive interface, role-based workflows, automated notifications, and integration with EDC systems and third-party vendors make it a comprehensive platform for clinical data coding from collection through approval.

Industry Certifications and Standards Compliance

• UMC certified B3/C3 vendor for WHODrug coding
• Licensed MedDRA vendor with full dictionary support
• Support for synonym dictionaries
• Behind-the-scenes updates to maintain adherence to the latest CDISC SDTM standards

Intuitive and Interactive Interface

• Available as both a powerful mobile app and a web application
• Wide range of filters to support methodical, structured coding
• Streamlined reports for detailed analyses of coded data
• Customizable and automated notifications delivered via push and email

Flexible Import and Export Capabilities

• Import data from any external source, including systems without web service technology
• Import coding configurations to maintain consistency across studies
• Export coding data to SAS, CSV, and Excel formats for downstream analysis

Streamlined Coding Workflow

• Batch processes for autocode, save, and review actions across large datasets
• Full audit trails of all coding activities to support compliance and regulatory expectations
• Independent review levels to maintain data integrity
• Customized coding review and approval workflows tailored to study needs
• Ability to leave comments on terms flagged for review

Multiple Coding Level Options

• Convenient display of low-level, high-level, and preferred codes within a single interface
• Rapid ATC reference and selection for drug coding
• Detailed descriptions of each term to be coded for informed decision-making

Versatile Dictionary Management

• Simplified upversioning to save significant time and resources when managing coding dictionaries
• Fast dictionary searches that reduce search time from minutes to seconds
• Synonym dictionary importing, management, and ongoing support
• Auto-coding capabilities for individual records or large datasets in bulk

TrialKit Coder requires active WHODrug and MedDRA subscriptions and is compatible with a wide range of existing EDC systems through its import and export functionality. Every coding action is tracked via audit trail to meet compliance and regulatory expectations, making TrialKit Coder a reliable choice for clinical trial teams seeking a certified, mobile-first medical coding platform.