Katherine Kacena Consulting

Katherine Kacena Consulting is a private biostatistics and clinical development consulting firm focused on drug, device, and diagnostic development. The business provides statistical support for clinical trial design, simulation, analysis, data monitoring committee statistics, and communications with regulators, patient groups, and investors. Its work spans development from preclinical through post-approval and covers therapeutic areas including oncology, cardiovascular disease, autoimmune disease, infectious disease, chronic pain, enzyme deficiencies, in vitro diagnostics, medical devices, and radiotherapeutics. The firm appears to be centered on the expertise of founder and principal statistical consultant Katherine Kacena rather than on an internal therapeutic product pipeline.