As a niche provider, Vita Data Sciences has handled several Sponsor rescue case studies since our inception. In this slide share (presented at PhUSE SDE in Boston), we aim to provide background of our NDA submission experience and present a rescue case study where our team worked with a Sponsor towards their final NDA submission packet, even though the Sponsor had outsourced these services to a global full-service CRO. We have provided a brief background and outline significant gaps identified in the deliverables, services we offered, and summarize lessons learned/recommendations which can come in handy for anyone who is starting to work on their NDA clinical datasets package. Your feedback and comments are welcome.