Supporting Clinical Research and Clinical Trials

The CRFG has a very experienced leadership team with extensive international pre-clinical, translational, and clinical research experience allied to global regulatory and reimbursement achievements. Our team includes the Interim Director, Professor Martin O’Donnell, and the CRFG Principal Investigators.

A number of investigators at the CRFG and GUH have experience in various aspects of clinical research in medical device development.

Prof Martin O’Donnell, Interim Director, is Principal Investigator of a number of studies including "Sodium InTake in Chronic Kidney Disease" (STICK), the "Clarifying Optimal Sodium Intake Project" (COSIP), and the HRB HRA "Sleep Hygiene Education for Blood Pressure Reduction" study (SLEPT) He was Principal Investigator of Phase I-IIb trials evaluating an external device (VenowaveTM) to treat severe post-thrombotic syndrome, which resulted in FDA approval. The Department of Cardiology at Galway University Hospital, particularly Prof Kieran Daly, has a strong track record of participating in randomized controlled trials evaluating cardiac medical devices in international randomized controlled trials. Prof Daly along with colleagues, Dr Jim Crowley, Dr Pat Nash, Dr Briain O’Neill and Dr Faisal Sharif are actively involved in clinical trials of medical devices in interventional cardiology. The experience gained in these clinical trials provides invaluable insights in the practical implementation of device studies at the CRFG.

Access to Clinical Specialists and Networks

We can provide access to a wide range of clinical specialists and networks to facilitate single centre and multi-centre clinical research trials.

Research Nurse Support

We can provide dedicated specialist research nurses with the skills and experience for your study needs. The nursing team, overseen by experienced Clinical Research Coordinator/Nurse Manager Caroline Kelly, and Early Phase Clinical Trial Manager, Veronica McInerney will ensure standard operating procedures are in place and will conduct your study in compliance with Good Clinical Practice and the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004. 

Pharmacy Support

Our dedicated pharmacy staff are experienced in the management of IMP for trials. We can help with protocol development and study set-up. We can provide controlled storage, drug accountability, dispensing, aseptic preparation, monitoring support and destruction of IMP, as required. Read More...

Biostatistics Support

The Biostatistics Unit can provide biostatistical and methodological support on study design and analysis. Read More..

Quality Support

Our Regulatory Affairs Manager, Emma Deenihan can offer advice and assistance with ethical and regulatory submissions. Read More..

Information Systems and Data Management

We have a dedicated team of Data Managers and Database Developers who can create validated databases and manage data for a variety of clinical studies from Phase I trials to Phase IV, observational studies and patient registries.

The information systems team can provide data management expertise and IT support at every stage of the project. IT services provided by the CRFG include the development of Electronic Case Report Forms (eCRF), database design and ongoing data management. Read more..

Biospecimen Storage and Processing

Our research support staff can assist with phlebotomy, sample handling and processing, storage and dispatch to external laboratories as required.

Collaboration on Horizon 2020

We offer partnering opportunities with industry for Horizon 2020 clinical research proposals.

Education Programmes

Our education programmes include:

- M.Sc. in Clinical Research
- M.Sc. in Biostatistics (Research)
- Summer School in Biostatistics

Our key benefits for industry are:

Skilled staff: Our highly experienced team can provide a range of services to facilitate delivering quality clinical trials.

Cost Effectiveness: The HRB-CRFG provides a cost effective and competitive service.

Efficiency: We have a dynamic team with streamlined processes to enable efficient clinical research project start up and delivery.

For further information on how the HRB Clinical Research Facility, Galway can help with industry-led clinical trials, contact:

Dr. Aideen O'Doherty,
Acting Programme Manager
Phone: 353-91-493918;
Email: aideen.odohertynuigalway.ie