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Case Study

150 Subject TQT Trial & 16 Subject “Cooperstown Cocktail 5+1” DDI Trial Exceeds Sponsor’s Goal for NDA Filing Target Date

A biopharmaceutical company awarded a parallel-designed Thorough QT (TQT) trial and a Drug-Drug Interaction (DDI) trial. Their aim was to meet an aggressive timeline to file their NDA within 6 months from the first subject screened. They needed fast startup, quick enrollment, and well-run trials to yield high-quality data to meet their target timeline.


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