Site Management Organization (SMO) services refer to structured operational support provided at the hospital or site level to assist Principal Investigators (PIs) in conducting clinical trials efficiently and in compliance with ICH-GCP standards.
At Big Leap Research, our SMO services are designed to enhance site performance while ensuring that the PI maintains full medical and scientific oversight of the study.
With experience supporting over 100 global clinical trials, our SMO model is designed to ensure protocol adherence, data integrity, and smooth coordination between sponsors, CROs, and hospital sites.
Core CRO Capabilities
Hospital Ethics Committee (IRB) Submission & Approval
Preparation, coordination, and follow-up of IRB submissions at hospital level, including amendments and continuing review documentation.
Patient Screening & Enrollment
Support in subject identification, pre-screening coordination, enrollment tracking, and compliance with inclusion/exclusion criteria.
Hospital Study Site Administrative Support
Operational coordination with hospital departments, contract processing support, document routing, and internal communication facilitation.
Clinical Research Document Management
Maintenance of Investigator Site File (ISF), essential documents, version control, and regulatory binder oversight.
Study Visit Support
On-site CRC support during patient visits, scheduling coordination, source documentation assistance, and visit documentation tracking.
Safety Reporting
Assistance in SAE reporting processes, safety documentation management, and timely communication with sponsor and IRB.
SMO Strengths
1.
Support for 100+ multinational, multi-center clinical studies
2.
Close collaboration with experienced PIs across major Vietnamese hospitals
3.
Structured CRC deployment model
4.
ICH-GCP compliant site operations
5.