Trial Operations, Coordination & Oversight
This service provides comprehensive coordination, operational management, and oversight for paediatric clinical studies, ensuring efficiency and compliance with regulatory, ethical, and scientific standards. Activities include study feasibility, site selection, contract negotiation, investigator meetings, training, project and IMP management, and setup/maintenance of ISF and TMF/CTMS, typically over one year. It supports investigators, sponsors, and research teams in harmonising activities across sites with streamlined communication and validated documentation.
