Q2BI

Q2BI, Corp. is a global biometrics and clinical data science contract research organization (CRO) for the life science industry including regulatory submissions. Founded in 2009, Q2BI has a broad range of expertise-based services in the areas of an AI/ML Data Visualization/Analytics software platform (Janus), Electronic Data Capture (EDC), Clinical Data Management (CDM), Medical Services (Medical Writing, Medical Monitoring, Medical Coding), Statistical Programming, Biostatistical science, Safety Monitoring including IDMC/DSMB, Pharmacokinetics / Pharmacodynamics (PK/PD), and System Validation Consulting. Q2BI is a pioneer in adopting CDISC and supported the world’s first FDA Project ORBIS.

Q2BI covers all clinical phase studies as well as regulatory submission-needed Biostatistics / Statistical Programming / Data Management services. We have conducted over 1,600+ studies with 50+ successful NDA/BLA submission approvals in various therapeutic areas. Our submission experience includes approvals with the FDA, EMA, NMPA (China), PMDA (Japan), MFDS (South Korea) and TGA (Australia) among many other regulatory agencies. We have grown steadily over years with long-term service and partnerships with many well-established as well as emerging mid-size and smaller companies in the life science world. Q2BI has earned our reputation for high quality, flexibility, excellent service and harmonized collaborations in meeting the needs and achieving the expectations of our various clients. We welcome the opportunity to partner with you!