Clinpex provides an AI-enabled clinical coding platform and managed services for MedDRA and WHODrug coding in clinical trials and pharmacovigilance. The platform combines AI-assisted and rule-based coding with built-in review workflows, dictionary versioning control, and audit trails for regulatory compliance. Clinpex also offers a coding API for software vendors and expert medical coding services for pharma companies and CROs.
Funding
Funding not disclosed
Founders
Product
Problem
Clinical coding for MedDRA and WHODrug dictionaries is a complex, high-stakes process that requires accuracy, consistency, and regulatory compliance. Many organizations rely on legacy systems or spreadsheet workarounds that are difficult to scale, lack built-in review workflows, and struggle to manage biannual dictionary version updates that can invalidate existing coded data.
Solution
Clinpex provides a comprehensive clinical coding platform that combines AI-assisted and rule-based coding with configurable review workflows, query management, and real-time reporting. The platform supports MedDRA, WHODrug (B3/C3 → MPID), IMDRF, and mappings, and can operate standalone or integrate with existing EDC and safety systems like Veeva, Rave, and Argus. Clinpex also offers managed medical coding services staffed by experienced coders, as well as a coding API for software vendors who want to embed coding capabilities directly into their applications. The platform includes dictionary versioning tools that analyze impact, control upversioning, and maintain full audit trails for regulatory compliance.
Target Audience
Primary customers are pharmaceutical companies, CROs, and software vendors who need accurate, scalable MedDRA and WHODrug coding for clinical trials, safety databases, and regulatory submissions.
Features
- AI-assisted and rule-based autocoding with on-demand or scheduled execution
- Advanced dictionary search supporting term text, code, wildcards, partial match, and complex logic with tolerance for spelling errors and medical variations
- Built-in review and query workflows with configurable quality control layers, synonym lists, "Do Not Code" and "Requires Review" rules, and reason-for-recode documentation
- Dictionary versioning with impact analysis, controlled upversioning, and side-by-side comparison of old and new versions for MedDRA and WHODrug
- Support for custom and investigational drug products not yet in standard dictionaries, with import/export capabilities
- CMQ and CDG creation and management via drag-and-drop interface with inclusion/exclusion criteria and impact analysis
- 21 CFR Part 11 compliance, SSO support, full audit trails, and organization-level data isolation
- REST API with secure authentication for embedding coding into external platforms