Biostatistics Delivers NDA Items at a Record Pace

PPD was challenged to submit an NDA within one year of the pre-NDA meeting, and within three months of database lock. The NDA contained electronic components and PPD developed new tools in order to make the process as smooth as possible.

Some of the new tools included validation tools and programming consolidation that made the process more efficient. Also, new programming macros allowed the team to design a simple electronic format of statistical tables, listings and figures.

As a result, the NDA was submitted on time with minimal questions for the FDA, and the tools that were developed will be put to use on future projects.