Case Study

Supporting A Sponsor From SPA Rejection To BLA Submission


A pre-commercial biopharmaceutical company came to Veristat for consulting services following rejection by the FDA of their application for a special protocol assessment (SPA). This outreach to Veristat was a result of the sponsor representatives having had a prior successful working relationship with our Biometrics team while at another biopharma organization. The sponsor’s SPA rejection was based primarily on the study protocol not having clearly defined endpoints, nor the statistical analysis plan having a comprehensive method for handling missing data, particularly in relation to the efficacy of the study drug.

From our initial consulting activities and FDA meeting attendance, we transformed the clinical trial design and the statistical foundation of the SPA, which helped drive the SPA to regulatory agreement. Our collaboration expanded to include Biostatistics and Statistical Programming for the first Phase III study, and Biostatistics, Statistical Programming, Data Management and Project Management for subsequent studies. Veristat supported the statistical analysis plan and statistical programming of the Integrated Summary of Safety (ISS).

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