Services
Clinical Development
Galilee Clinical Bio Research provides full CRO services to coordinate clinical trials at leading Israeli, European, US, LATAM, and Australian medical centers. A respected and accomplished clinical development partner, Galilee oversees operational and administrative tasks, so companies can focus on verifying product safety and effectiveness.
Site identification and feasibility assessment
Submission of applications to local and national ethics committees (e.g., IRBs and MoH)
Planning and execution of investigators’ meetings
Pre-study visits
Initiation visits
Interim monitoring visits
Close-out visits
Handling and resolution of AEs and SAEs
Maintaining close contact with the site team
Preparation for site audit/inspection
Recruitment enhancement activities and support
Executing clinical trial agreements/contracts
Assistance in the import of investigational product/device
Investigational medicinal product/medical device storage and accountability
Medical writing: Protocols, CRFs, monitoring plans, and more Informed Consent Form translations
CRF development—whether electronic or paper
Investigational product/device labeling
Clinical project management
Production and maintenance of essential study documents
Data management and biostatistics
Recognizing, maintaining, and coordinating outlines, budgets, and resources
Supervision of the full implementation of contracts
Evaluating risk factors and offering suitable substitutes when necessary
Assessing study progress and coordinating the relevant teams
Early Development Services
Pre-clinical program design and development
Performing pre-clinical studies for proof of concept
Phase I and PK/PD clinical trials