Biostatistical Consulting Inc. (BCI) provides biostatistical and programming services to the biotechnology, pharmaceutical, and medical device industries. The vast majority of our work is in the design and analysis of clinical trials, although we also have experience with designing and analyzing epidemiology studies and patient registries. BCI employs a select group of biostatisticians and statistical programmers, all of whom have advanced degrees in statistics and whose substantial experience ranging up to more than 30 years spans Phase 1 to Phase 4 clinical trials in a broad range of therapeutic areas. Our staff have experience with INDs, NDAs, and BLAs and with IDEs, PMAs, and 510(k)s. BCI offers all of the following services: - Strategic statistical consulting - Study design - Sample size and power calculations - Writing statistical sections of protocol - CRF review - Randomization - Statistical analysis plan development - Statistical analyses - Table, listing, and graph production - Writing statistical sections of Clinical Study Report - Integrated Summaries of Efficacy and Safety - Statistical representation with FDA and European regulatory agencies - Data Monitoring Committee participation and support