Q2BI, Corp. (Q2BI) is a biometrical and clinical data science contract research organization (CRO) for biopharmaceutical product/drug development and regulatory submissions, with a broad range of expertise-based services in the areas of electronic data capture (EDC), clinical data management (CDM), medical coding (MC), Statistical Programming, Biostatistics, safety monitoring including IDMC/DSMB, Pharmacokinetics/Pharmacodynamics (PK/PD), Medical Writing, Data Visualization and System Validation Consulting since 2009.
Q2BI covers all clinical phase studies as well as regulatory submission-needed Biostatistics/Programming/Data Management (BPDM) services. Q2BI has been a global CRO since 2009 and has grown steadily over years with long-term service for and partnerships with many well-established as well as newly emerged companies in the life science world. Operating in North America (with headquarters and two offices in the Boston area including Cambridge and footprints in greater New York and the San Francisco metropolitan areas), Australia (Melbourne). Malaysia (Kuala Lumpur) and China (with footprints in Guangzhou, greater Shanghai and greater Beijing metro areas), Q2BI has won its reputation for its high quality, flexibility, excellent service and harmonized collaborations in meeting the needs and achieving the expectations of variety sized of pharmaceutical clients.
At Q2BI, we put great endeavor in helping, understanding and meeting the scientific aspects of any in-contract development project, with priority focus on high quality of our work and deliverables. We trust our employees are the greatest talent and asset, who are provided with unique, project sponsors-based Project Manager system and project-team setting for daily performances and demonstrations.
Q2BI team has experienced over 1,800 studies and 54 successful NDA/BLA submission approvals in various therapeutic areas. Q2BI is a pioneer in adopting CDISC and Q2BI team supported the world's first FDA Project Orbis | FDA.