CRO pharmacovigilance division delivering ICSR processing, signal detection, aggregate reporting, medical review and J-QPPV / local-QPPV services with strong PMDA expertise.
PV capability iCounts how many of the 13 core PV service capabilities this profile lists (ICSR processing, SAE handling, signal detection and more) - each adds 4 points, capped at 52 - plus 2.5 points per therapeutic area covered, capped at 30, and a case-volume capacity tier worth up to 18 (18 at 1M+ cases/yr, 14 at 500K+, 10 at 200K+, 6 at 50K+, 3 for any volume). Levels: 80+ Comprehensive PV | 60-79 Broad capability | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
67Broad capability
Regulatory reach iAdds 5 points per regulatory agency covered, capped at 45, plus 18 points for global QPPV support, 12 for local QPPV support and 5 for QPPV availability, and 6 points per geographic region covered, capped at 25. Levels: 80+ Global reach | 60-79 Multi-region | 40-59 Regional | below 40 Limited. Whether this dimension matters for you depends on your specific project.
79Multi-region
Safety technology iAdds 12 points per safety database or analytics platform listed, capped at 48, plus 22 points for AI-assisted safety monitoring, 16 for signal detection capability and 14 for signal management. Levels: 80+ Cutting-edge | 60-79 Advanced | 40-59 Developing | below 40 Foundational. Whether this dimension matters for you depends on your specific project.
88Cutting-edge
Aggregate reporting iAdds 7 points per aggregate report type offered (PSUR, PBRER, DSUR etc.), capped at 40, plus 7 points per risk-management service, capped at 30, then 16 points for medical review capability and 14 for benefit-risk assessment. Levels: 80+ Comprehensive | 60-79 Strong | 40-59 Solid | below 40 Basic. Whether this dimension matters for you depends on your specific project.
93Comprehensive
Quality & compliance iBlends on-time submission rate (0.3 points per percent, up to 30), average case processing speed (20 points at 3 days or less, 15 at 5 or less, 9 at 8 or less, else 3), compliance flags (GxP 14, ISO 10, GDPR 8, HIPAA 8) and audit findings last year (10 points for zero, 7 for one, 3 for up to three). Shows Not reported when no submission rate, processing time, ISO or GxP data is on file. Levels: 80+ Exceptional | 60-79 Strong | 40-59 Solid | below 40 Developing. Whether this dimension matters for you depends on your specific project.
32Developing
Capacity & scale iTiers the PV professional headcount up to 30 points (30 at 1500+, 24 at 500+, 17 at 150+, 10 at 40+), annual case-volume capacity up to 28 (28 at 1M+, 22 at 500K+, 15 at 200K+, 9 at 50K+) and active clients up to 22 (22 at 200+, 17 at 80+, 11 at 25+, 6 at 5+), plus 5 points per geographic region covered, capped at 20. Levels: 80+ Enterprise scale | 60-79 Large | 40-59 Mid-size | below 40 Boutique. Whether this dimension matters for you depends on your specific project.
20Boutique