Case Study - Accomplishing a Seamless FDA Submission

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Background

Our client is a pioneering biotechnology company with years of experience in microbiome therapeutics. While the client managed the core aspects of their programs, Cytel played a crucial role by offering extensive biostatistics and programming support, and expertise in regulatory affairs.

The 7-year engagement with the client included interim and final analyses and the creation of a comprehensive CDISC package, which included SDTM and ADaM datasets. Additionally, Cytel’s scope was extended to cover the subsequent extension study.

Client Challenge

Reconciliation of data from the central laboratory and the derivation of the primary endpoint presented challenges. Furthermore, both studies underwent protocol amendments that introduced variability in the study design from patient to patient. These amendments also added complexity to the database, requiring substantial and frequent programming updates to accommodate the evolving study parameters.