Global Biostatistics & Statistical Programming Scale-Up
Client background
A top three pharmaceutical company seeking a partner to stabilize study timelines and consistently meet regulatory submission deadlines.
Challenge
Insufficient internal capacity and specialized statistical programming expertise across therapeutic areas—especially oncology—created schedule risk for new studies and submissions.
Engagement
Ephicacy was selected as the global partner for Biostatistics and Statistical Programming, providing a cost-efficient model designed to enhance data quality, analytics, and submission readiness.
Ramp-up
- Within 12 months, we deployed 50+ programmers across the sponsor’s studies.
- The team expanded toward ~100 biostatistics and programming consultants over the subsequent 6 months.
Delivery model
- Hybrid support provided from both India and the United States, covering study-level programming and higher-level statistical consulting.
- As our delivery matured, India became the primary delivery hub, supported by U.S. continuity to optimize cost and coverage
Efficiency & standardization
- Deep familiarity with the sponsor’s systems and processes enabled streamlined workflows.
- We identified cross-study redundancies and drove standardization across Ephicacy-supported programs, improving programming efficiency and statistical modeling consistency.
Impact
- Strengthened adherence to study timelines and regulatory submission schedules
- Expanded, flexible capacity across oncology and other therapeutic areas
- Improved data quality and analysis rigor within a cost-efficient operating model
