8 pages
Pharmacovigilance, across the lifecycle. for the lifecycle.
The continuity story from Phase 1 through twenty-plus years of postmarket surveillance. Citation-bound attribution, MedDRA coding, ICSR-ready output, and the architectural argument for keeping a single platform across the drug lifecycle.
For PV leadership, MedDRA stewardship, and the postmarket safety bench
- Lifecycle architecture: clinical trial through postmarket surveillance
- Citation-bound attribution under WHO-UMC and Kramer
- MedDRA coding pipeline with active validation
- ICSR-ready output for downstream PV platforms
- The argument for one platform across the drug lifecycle
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