Primary point of contact for clinical innovation and research, facilitating industry and academia.
Consultation on regulatory pathways and provision of advice on conduct of clinical research in all fields.
Streamlined process with coordination and oversight through the central office and dedicated resource in the CRF/Cs to navigate local systems and engage with Investigators, ultimately leading to efficient and timely identification of sites.
Regulatory and Ethics
Management of the application process, including preparation and submission of study documents when feasible.
Range of supports available to optimise start-up activities, including central coordination and dedicated resource in CRF/Cs accelerating all aspects of the process at the site level.
Tracking/monitoring of recruitment targets. Collation of metrics across CRF/Cs and provision of advisory support.
Audit and Monitoring
Oversight of study conduct through risk based plans and activities, with reporting to sponsor.
Ensured through a team of quality managers located across the central office and CRF/Cs, facilitating best practice and harmonisation across the network.
Provision of resources, including templates, guidance and signposting to training and education programmes, as appropriate.
Consultancy support from product concept to commercialisation.
Ambassadors for Irish clinical innovation and research, nationally and internationally.