Phastar provided a team of statisticians and programmers to deliver the analysis and reporting of a program of four trials in a genetic rare disease, and the corresponding integrated summary of efficacy and safety, to support a regulatory submission to the FDA. There were four studies comprising twelve, one, two, and three patients. The one and two patient studies were pilot studies that included historical data from hospital notes that had been transcribed into a new clinical trials database (after obtaining informed consent from the patients). The three patient study was a compassionate use study that had been initiated due to patient requests.
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