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Supporting a Sponsor from SPA Rejection to BLA Submission

Following a SPA rejection, our team was brought in by the sponsor to revise the Phase III protocol and statistical analysis plan for resubmission to the FDA, leading to SPA approval. The client expanded our relationship to include Statistics, Statistical Programming, Data Management, and Project Management of four Phase III studies which culminated in the planning and programming of an ISS for submission of the BLA.

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