Big Leap Research provides structured clinical and scientific consulting services to support sponsors, investigators, and institutions conducting research in Vietnam.
From early study concept and protocol development to regulatory pathway planning and operational feasibility, we deliver practical, evidence-based advisory aligned with both Vietnamese regulations and international ICH-GCP standards.
1.
Study Design & Scientific Development
2.
Clinical trial design, protocol development, endpoint strategy, and feasibility alignment.
3.
Regulatory & Compliance Advisory
4.
MOH and IRB pathway planning, submission strategy, and regulatory readiness assessment.
5.
Operational & Feasibility Strategy
6.
Site selection advisory, recruitment forecasting, and budget modeling.
