Clinical Trials

The INFANT Clinical Trials platform represents the expertise of obstetricians, neonatologists, paediatricians, midwives, research nurses, biostatisticians and clinical trial managers at our centre.

Over the last decade, we have accrued extensive experience of all types of clinical trials ranging from cohort studies to definitive interventions in the perinatal space including the Clinical Trials of Investigational Medicinal Products (CTIMPS) and Clinical Investigations.

This has facilitated the acquisition of uniquely valuable skillsets, personnel and infrastructure. We have ‘in-house’ expertise in clinical trial management including trial design, trial monitoring, reporting, database design and implementation, biobank development and curation, biostatistics and trial methodology. In addition, we have considerable expertise in ethical, regulatory and industry requirements.

Platform supports are provided by the INFANT; Biobank, Data Hub, Early Life Lab, Operations Team, Research Team which are all underpinned by the ISO accredited INFANT Quality Management System. In house TransCelerate accredited training ensures that all staff are GCP trained.

Each of INFANT’s PIs provide expertise and guidance to the Clinical Trials Platform.

As a research centre focused entirely on pregnancy, birth and early childhood, clinical leadership is important. Dr Keelin O’Donoghue (Consultant Obstetrician), Prof Eugene Dempsey (Consultant Neonatologist), and Prof Deirdre Murray (Consultant Paediatrician) provide clinical expertise and support in their respective areas.

Professor of Midwifery Declan Devane is Director of the Health Research Board – Trials Methodology Research Network (HRB-TMRN) and provides Trial Methodology expertise and clinical support to INFANT.

Competencies

• Neurodevelopmental Follow-up
• Biobanking
• Omics platform
• Data Management
• Training
• Quality Management System