Datasheet | September 9, 2022

NDA/MAA Preparation Survival Guide: Overcoming Data Analysis Hurdles

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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
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