Biomedical Statistical Consulting

Biomedical Statistical Consulting is a private, FDA-focused biostatistics and regulatory consulting firm serving life science sponsors, especially in medical devices, diagnostics, and therapeutics. The company provides study design, statistical analysis, regulatory strategy, and submission support across the clinical development lifecycle, from early feasibility work through pivotal trials and post-submission interactions. BSC is particularly known for approval-oriented biostatistics in highly regulated settings, with expertise in PMA, IDE, Bayesian and adaptive trial designs, propensity score methods, and real-world evidence integration. Founded in 1986, the firm operates as a specialized CRO/consultancy rather than a drug developer, helping sponsors generate submission-grade evidence and navigate FDA review.