“In vitro efficacy study of a new plasma-derived Factor V concentrate in patients with congenital Factor V deficiency (parahemophilia)”

Support in the planning, initiation, and conduct of clinical studies in accordance with Good Clinical Practice (GCP). Management of relations with the Ethics Committee and Clinical Research Unit, including preparation and submission of regulatory documentation, responses to requests for clarification, amendments, approvals, renewals, safety notifications, and study closure. Clinical data management, including design and review of paper/electronic Case Report Forms (CRFs), data entry, validation, quality control, cleaning, query management, and discrepancy resolution. Monitoring of study progress and compliance with protocols, timelines, and procedures. Collaboration with the Principal Investigator, Study Coordinator, Monitor, and Sponsor to ensure data accuracy and completeness. Management of the Trial Master File and Investigator Site File, with support during audits and inspections.