Delivering Topline Results 36 Hours After Database Lock
Situation: A Phase 4 pediatric study
The Success: Our Sponsor was thrilled when we delivered extensive final topline safety and efficacy results 36 hours after database lock. It didn’t come at the cost of data quality. We had zero randomization, treatment assignment and treatment errors with a BID dosing regimen that required some children to receive medication at school. Also, subject retention was 100%.