Case-processing provider offering ICSR intake, SAE handling, literature surveillance and follow-up management with NMPA coverage.
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.
25Focused
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.
11Limited
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.
12Foundational
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.
14Basic
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.
14Developing
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.
5Boutique