Team size of 200+ across USA and INDIA
Highly experienced team with about 50% staff having >10 years of clinical trial experience
100+ trials executed to date across 300+ sites
Database of 500+ sites across therapeutic areas
Have supported 40+ ANDA, 15+ MAA, and 18+ 505(b)(2) NDA submissions
Working relationships with clients from the US, EU, China, South Korea, and India
Participated in 25+ scientific advisory meetings with USFDA, EMA, CDSCO
Robust experience across 10+ therapeutic areas
Handled a wide range of studies from complex FIH studies to late phase trials with a sample size of up to 1500 patients
Experience of working on trials with lengthy patient follow-ups (up to 5 years)
Track record of 90% patient retention across therapeutic areas
Handled 10+ complex studies and 5+ rescue studies
Experience across 9+ EDC platforms
Global Library of 250+ standard CRFs
200+ deliverables like Interim analysis, dose-escalation meeting, DSMB, marketing authorization etc.
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