Phastar was contracted to assist a global pharmaceutical company with their integrated summary of safety and efficacy for a regulatory submission. The work started with assisting the sponsor in defining an integration strategy for approximately 20 phase I studies, six phase II studies and their corresponding extension as well as three phase III studies and their long-term follow-up study. It involved defining a set of relevant analyses sets and reporting periods for both safety and efficacy analyses, ahead of writing up the analysis plans for the phase II pooled analyses, and phase II & III pooled analyses.
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