BioPier Company History

BioPier Business Proposition

Biostatistical analysis is a crucial and time-consuming step in drug development, as it ensures the safety and efficacy of each drug. Despite the specificity of each clinical study, 70% of the work can be standardized due to regulations. BioPier's expertise in this process enables clients to improve the quality and speed of drug development while reducing costs.


Founder Lixin Gao established BioPier in 2006. The company's mission: to develop an enterprise application, standardizing 70% of similar tasks and, in doing so, empower biopharma and CRO companies to conduct self-directed reviews, validation, and analyses of clinical study data. Using Gao's expertise in application and drug development, he and his team team spent for three intensive years to develop the processes to achieve this goal.In 2009, BioPier released Clinical Workbench, the first enterprise web-based application for data review and analysis, which was met with great acclaim from the Boston-area biopharma community.


In response to the changing regulatory environment and client demands, BioPier initiated small-scale SAS programming services to support their client's product development and marketing needs. This became the launch pad for BioPier's subsequent transformation into a leading CRO specializing in biostatistical programming.


In 2015, BioPier fully transitioned away from its product-based roots into a service-based CRO, specializing in biostatistical programming. As such, BioPier outclasses its competition thanks to its innovative technology and leading efficiency levels. BioPier continues a boutique company culture to the satisfaction of both team members and loyal clients. Small in terms of headcount, the BioPier team punches above its weight in terms of impact and deliverables and stands out for unparalleled per-person productivity. Remarkably, the BioPier team produces full phase-3 study analyses from scratch within an unmatched four months. Clients frequently enlist BioPier to salvage phase-3 studies mishandled by big-name CROs. Over nearly a decade, BioPier has completed more than 150 clinical studies and contracts, the bulk of these being pivotal late-phase studies for submissions. All in all, the company has earned five NDAs/BLAs and a series of sNDA/sBLA approvals for its clients. In 2022 alone, BioPier contributed three sBLA approvals.