Client : US based Biotechnology Company

Services provided:

• Clinical Monitoring Oversight
• Site Contracting
• Protocol and ICF Amendments
• DCGI Application Review and Support
• Presentation to SEC
• DCGI Approval
• EC submission, Queries handling and Approval
• Central lab management and Coordination
• Medical Monitoring
• Safety and SAE Management and DCGI Reporting
• Site Management for the study
• Study Coordinator provision at site
• Lab kit imports and shipment support and coordination
• Working with the monitoring CRO for data resolution and query management
• Site budgets and payment coordination
• Site Close Out Activities