Protocol Clinical Consulting LLC
Pharmaceuticals - Austin, Texas, United States
Protocol Clinical Consulting LLC Employees
Protocol Clinical Consulting LLC Details
Protocol Clinical Consulting provides project management and operations support for clinical research and development.Study Management:CRO and vendor managementPatient recruitment and enrollment initiativesCross-functional and clinical team managementRegulatory:Essential document collection and IRB submissions Audit readiness trial master file reviewsIND/NDA submission preparation and advisory committee meeting supportSafety Data Monitoring:Endpoint & Event AdjudicationDSMB/DMC CoordinationSAE and data reconciliationMonitoring & Site Management:Visit report review and trackingLead CRA and CRA ManagementGCP and Protocol-specific TrainingStrategic Operations: SOP development Process improvement initiativesScientific Meeting Coordination: Investigator meeting planning and event coordinationScientific and Educational meeting seriesKOL/HCP interaction managementCommunication planning, meeting logistics and facilitation
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