NDA/MAA Preparation Survival Guide: Overcoming Data Analysis Hurdles

A biostatisical programming team's ability to strategically migrate and produce clinical trial data outputs in submission-ready format represents a key opportunity to reduce timelines without sacrificing data quality. Well established timelines, technical processes and careful communication are the keys to achieving a shortened timeline while preserving the quality of the marketing application.

Keys to coping with tight submission timelines:

• Involve key reviewers from the start
• Develop strategic timeline
• Practice with dry runs
• Coordinate integrated and CSR analyses