Pivotal trials & global expansion

Designing pivotal studies with global impact.

Key Services

We guide sponsors through regulatory-aligned pivotal trials and international expansion planning.

Regulatory strategies for U.S., EU, Canada, Japan, and Australia
Regulatory strategies for U.S., EU, Canada, Japan, and Australia
Regulatory strategies for U.S., EU, Canada, Japan, and Australia
Optimized trial designs for efficiency and impact
Optimized trial designs for efficiency and impact
Optimized trial designs for efficiency and impact
Cross-regional planning for evidence generation to support commercialization and payer requirements
Cross-regional planning for evidence generation to support commercialization and payer requirements
Cross-regional planning for evidence generation to support commercialization and payer requirements

Our Approach

  • Design protocols tailored to regional regulatory frameworks and coordinate cross-border submissions

  • Select comparators and endpoints, refine statistical strategy, and integrate regulatory feedback

  • Align with HTA expectations and plan evidence to support reimbursement and geographic prioritization