Site Management Organization

Our team works together with the investigators from the early planning stages to ensure that the appropriate recruitment strategies are identified and discussed.

Site Support Services:

Central laboratory, central ECGs, IVRS and EDC procedures
Searching database for eligible patients
Confirming patient eligibility criteria
Patient retention
Maintenance of study documents
Enrollment enhancement
Solving and forwarding SAEs and queries
Resupply of IP and study materials
Soft and final database lock
Archiving of study documents

Training:

Face-to-face training with study personnel in protocol and other trial requirements
Preparation, maintainance and submission of IND critical documents
Maintenance of Investigator Study File and source documents
Completion of CRF and study documents
Laboratory procedures
IVRS, EDC, Central laboratory re-training
Using of study devices

By establishing and excellent raport with our study sites, we assist the investigators in finding effective solutions when they faced the challenges of the research.