Phastar partnered with a biotechnology sponsor to manage statistical and data management activities for a late-stage clinical study in Parkinson’s disease. The project involved distributed teams, complex neurosurgical procedures, and questionnaire-driven endpoints—all under tight budget oversight.
Key Challenges:
- Global team coordination across multiple time zones
- Limited internal statistical and data management expertise
- Complex CRF design for neurosurgical injections and questionnaire-based endpoints
- Need for strict oversight and cost control
Our Approach:
- Scheduled cross-time-zone meetings to maximize participation and maintain momentum
- Provided clear, proactive explanations to support sponsor understanding at each stage
- Conducted detailed multidisciplinary reviews of complex CRF pages
- Ensured strict adherence to the project timeline to minimize rework and control budget impact
Outcome:
The study progressed smoothly, earning strong praise from all stakeholders. The sponsor commended Phastar’s professionalism, attention to detail, and proactive approach, noting significant improvements in collaboration, clarity, and project efficiency.
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