Services

Clinical Development

Galilee Clinical Bio Research provides full CRO services to coordinate clinical trials at leading Israeli European and US 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

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