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