Expert Medical Coding. Delivered to Your Timelines.
Human expertise combined with AI-assisted tools to code MedDRA and WHODrug with accuracy, consistency, and full regulatory compliance.
- MedDRA and WHODrug coding by experienced coders
- AI-assisted workflows for faster throughput
- Configurable quality review and QC processes
- Full-service or overflow support—scaled to your needs
Coded by Experts, Powered by Tools
We combine experienced medical coders with intelligent, AI-assisted workflows to deliver accurate MedDRA and WHODrug coding at scale—without sacrificing quality or control.
Every project is staffed by coders with clinical trial expertise and supported by structured review and query management workflows.
- Coders with clinical trial and pharmacovigilance experience
- AI-assisted pre-coding to accelerate throughput
- Configurable review layers and QC workflows
- Structured query management for data clarifications
- Full audit trails for every coding decision
- Powered by the Clinpex Coding Platform
MedDRA Coding Across All Data Domains
From adverse events to medical history, we code verbatim text to the correct MedDRA hierarchy with precision and consistency.
Accurate MedDRA coding across all clinical and safety data domains, for any study phase.
- Adverse events and serious adverse events (all severity grades)
- Medical history, prior conditions, and diagnoses
- Indications and cause of death coding
- Multi-study synonym list management for consistency
- Support for current and historical MedDRA versions
WHODrug Coding—Standard and Investigational
We code medications to WHODrug B3 and C3 (MPID), including investigational and company-specific drugs not yet available in the standard dictionary.
Complete drug coding coverage—from approved medications to study-specific investigational compounds.
- WHODrug B3 (preferred name, ATC classification) coding
- WHODrug C3 MPID coding
- Concomitant and prior medication coding
- Investigational and company-specific drug handling
- Clear identification when coding maps to custom drug products
Working with investigational or company-specific drugs?
Quality Built Into Every Step
Every coded dataset goes through a structured QC process with configurable review layers, query management, and full audit trails—so you can submit with confidence.
Configurable quality workflows ensure consistency and traceability from first-pass coding through final delivery.
- First-pass coding by the team
- Second-pass quality review by a senior coder
- Sponsor query management and resolution
- Reason-for-recode documentation for full traceability
- Synonym propagation to maintain consistency across similar terms
- Audit-ready output for regulatory submissions
- "Do Not Code" and "Requires Review" rule enforcement
Flexible Engagement Models
Whether you need a full-service coding partner or overflow support during peak periods, we adapt to your volume, timelines, and existing processes.
We work the way you need us to—and scale as your studies do.
- Full-service coding for studies of any size or phase
- Overflow and backfill support during high-volume periods
- Short-notice capacity for urgent or rolling timelines
- Embedded model: our coders work within your existing systems
- Ongoing coding for long-term safety databases
- Standalone or integrated with your EDC and safety platform
Not sure which model fits your situation?
Ready to Discuss Your Coding Needs?
Tell us about your studies and timelines—we'll show you how Clinpex can deliver accurate, consistent coding at the pace you need.