Protocol Clinical Consulting LLC

Protocol Clinical Consulting provides project management and operations support for clinical research and development. Study Management: CRO and vendor management Patient recruitment and enrollment initiatives Cross-functional and clinical team management Regulatory: Essential document collection and IRB submissions Audit readiness trial master file reviews IND/NDA submission preparation and advisory committee meeting support Safety Data Monitoring: Endpoint & Event Adjudication DSMB/DMC Coordination SAE and data reconciliation Monitoring & Site Management: Visit report review and tracking Lead CRA and CRA Management GCP and Protocol-specific Training Strategic Operations: SOP development Process improvement initiatives Scientific Meeting Coordination: Investigator meeting planning and event coordination Scientific and Educational meeting series KOL/HCP interaction management Communication planning, meeting logistics and facilitation