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Q2BI is an established biometrical and clinical science contract research organization (CRO) specializing in biostatistics, data management, statistical programming, regulatory submissions (NDA/BLA), pharmacokinetics/pharmacodynamics consulting and operations for biopharmaceutical product development. The company has supported over 1,000 studies and contributed to at least 34 successful NDA/BLA approvals across diverse therapeutic areas. They are recognized for expertise in electronic data capture (EDC), medical coding (MC), safety monitoring and pioneering adoption of industry standards such as CDISC. Their team supported the world's first FDA Project ORBIS submission.
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