This US based biopharma company required an electronic submission package for over 13 studies to be submitted to the US FDA. Of these 13 studies, 11 studies only had SDTM datasets, and the remaining two studies had both SDTM and ADaM datasets.
Download this case study to learn how we leveraged MetaVate Define Module to expedite the normal define.XML project from a week to two days per study including Pinnacle 21 validation, leading to a successful submission to the US FDA in time.