Supporting Successful Clinical Research in Vietnam
With over 10 years of experience in Vietnam’s clinical research environment, Big Leap Research provides structured and reliable CRO services to pharmaceutical, biotechnology, and medical device sponsors.
Over the years, we have established working relationships with more than 52 hospitals across Vietnam, including major tertiary and academic medical centers, as well as collaborations with leading Key Opinion Leaders (KOLs) across multiple therapeutic areas. This network supports feasibility assessments, site activation, and patient recruitment in a practical and coordinated manner.
Our approach emphasizes regulatory compliance, operational clarity, and consistent communication throughout the study lifecycle.
Core CRO Capabilities
Regulatory & Ethics Submissions
1.
Dossier preparation and submission to MOH and Ethics Committees
2.
Regulatory pathway planning
3.
Amendment management and authority correspondence
Study Start-Up & Site Coordination
1.
Feasibility assessment and site selection
2.
Investigator and KOL engagement
3.
Contract and budget coordination
4.
Site activation management
Clinical Monitoring
1.
On-site and remote monitoring
2.
Source Data Verification (SDV)
3.
Documentation oversight aligned with ICH-GCP
Project Management
1.
Timeline tracking and milestone monitoring
2.
Risk identification and mitigation
3.
Structured sponsor reporting
Quality & Inspection Support
1.
SOP-based quality systems
2.
Support during sponsor and regulatory inspections
3.
CAPA follow-up and documentation review
