Datasheet | September 9, 2022

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

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader