Effective Clinical Trial Management and Regulatory Expertise Leads to FDA Approval of Unique Product for ADHD
Situation: Full-service management of two Phase 3 ADHD studies + NDA Submission = FDA Approval
- Initially contracted for End of Phase 2 meeting support due to ADHD expertise, which led to full service management of both Phase 3 studies and subsequent NDA authorship and submission.
- Study # 1: Laboratory Classroom Study leveraged existing relationships with Rho’s go-to network of experienced classroom sites and training consultants.
- Study # 2: Examined a novel endpoint to address unmet need/gap in typical coverage period for existing ADHD medications.
- Seamless team integration between clinical monitoring, data management, and biostatistics to identify early data trends leading to training reinforcement needs for new endpoint scales.
- Produced topline results within 24 hours of database lock.
- Parallel development of clinical study reports (CSRs) and Safety/Efficacy modules to support efficient NDA submission and successful label negotiation with FDA.
Rho and the sponsor jointly navigated a new pathway from initial End of Phase 2 planning to Phase 3 trial execution to delivery of quality data to support FDA approval.