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Clinical Trials

GTO team brings years of professional experience in clinical development that will allow professional and efficient service on all stages of a clinical development program. Clinical activities span from planning of clinical trial protocols, through execution, data collection, to analysis and reporting.

GTO Clinical team is also well experienced with developing clinical development plans and work in Israel and the global arena.


Clinical services include:
Study Start-up
• Trial planning and project management
• Site identification, qualification and selection
• Investigator identification and recruitment
• Investigator agreement/payment
• Study supply management
• Central laboratory services
• Central laboratory management

Study Documents
• Study/regulatory manual preparation and distribution
• CRF design, development, printing and shipping
• Preparation, submission and tracking of ethics documentation
• Protocol writing and development

Study Personnel 
• Investigator and initiation meeting planning and organization
• Site training
• Investigator/patient recruitment and retention strategies
• Medical monitoring

Site Visits 
• On-site monitoring (pre-study, initiation, routine, close-out)
• On-site audits
• ICH-GCP compliance
• Query and discrepancy resolution
• Site training and education

Biometrics 
• ICH E9 compliance
• CRF design (EDC or paper)
• e-CRF (EDC)
• Database design and creation
• Data entry and cleaning
• Statistical analysis plan
• Analysis tables, listings and graphs
• Online data review
• Interim analyses
• Integrated summaries of efficacy and safety
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