Dictionary Upgrades. Controlled, Compliant, Complete.
Every MedDRA and WHODrug release introduces changes that ripple through coded data, synonym lists, and medical queries. We manage the entire upgrade—so you move forward without disruption.
- Impact analysis before a single term is touched
- Controlled upversioning of coded data with full review
- Synonym list impact handled end to end
- Complete audit trail and regulatory-compliant documentation
More Than a Version Number
MedDRA and WHODrug releases twice a year. Each release can introduce new terms, retire terms, make hierarchy changes, and split or merge concepts—all of which can invalidate existing coded data without warning.
For organizations running active studies or maintaining safety databases, staying current is not optional — getting it wrong creates more risk than staying behind. The challenge is not just recoding: it is understanding what changed, what is affected, and what decisions need human review before any data is touched.
- New terms may supersede previously coded assignments
- Hierarchy changes can affect LLT-to-PT-to-SOC mappings
- Split or merged terms require coder judgment—not just a lookup
- All changes must be documented for regulatory traceability
Not sure how many terms your data will be affected by?
End-to-End Upgrade Process
We run the full upgrade cycle—from impact analysis through delivery—with structured review at every step and a complete record of every decision made.
A repeatable, documented process built around your data, your timelines, and your review requirements.
- Load old and new dictionary versions side by side for comparison
- Run impact analysis to identify all affected coded verbatims
- Categorize changes: auto-resolvable vs. requires coder review
- Apply auto-resolvable changes with approval from your team
- Manual review and recoding of ambiguous or split terms
- QC pass to validate consistency across the updated dataset
- Deliver updated data with full change documentation
MedDRA & WHODrug—Both Covered
Whether you are upgrading MedDRA for adverse events and medical history, or WHODrug for medications, we handle each dictionary's specific versioning model and change types.
MedDRA
- Biannual releases (March & September)
- New, retired, and modified LLTs and PTs
- Hierarchy restructuring across SOC, HLGT, HLT
- Primary and secondary SOC assignment changes
- Full LLT → PT → HLT → HLGT → SOC impact traced
- Upgrade from any prior version, not just the preceding one
WHODrug
- Biannual releases (March & September)
- New, modified, and withdrawn drug records
- ATC classification additions and reassignments
- MPID-level changes in C3 coding
- Investigational and company-specific drug handling
Audit-Ready, Regulatory-Compliant
Every upgrade we deliver includes complete documentation of what changed, why, and who reviewed it—so your data remains submission-ready from day one of the new version.
- Full audit trail for every recoding decision
- Reason-for-recode captured for each changed verbatim
- Change summary report comparing old and new coded data
- 21 CFR Part 11 compliant coding environment throughout
- Data security and organization-level isolation
Ready to Plan Your Next Dictionary Upgrade?
Tell us your current version, target version, and what is in scope—we will outline an approach and timeline that works for your team.