Quality and Regulatory Affairs Manager

Emma Deenihan‌

The Quality and Regulatory Affairs Manager, Emma Deenihan, has over 10 years of experience of working in a regulated environment; including 4 years experience of working in quality assurance in the medical device industry, and 4 years experience of working with clinical trials and in clinical research.

She has excellent working knowledge of quality management systems, EU Directives 2001/20/EC and 2005/28/EC, ICH GCP, MDD, 21 CRF 860, IVDD, ISO 13485:2003, ISO 14155-1, ISO 14155-2, and other Irish and International Standards and Regulations. She has participated in, and chaired, external quality systems audits by the IMB, FDA, EU and other International regulatory organisations.

The Quality and Regulatory Affairs Manager offers advice and assistance with regulatory and ethical submissions to the Irish Medicines Board, and the Central Ethics Committee. She works closely with the study management team as a source of quality and regulatory advice on the interpretation of information to ensure adherence with ICH GCP and relevant regulations. She also provides leadership in quality and regulatory decisions to ensure compliance across the life cycle of a study.

Senior Lecturer in Biostatistics

Dr. John Newell

Dr. Newell is a Senior Lecturer in Biostatistics and Head of the Biostatistics Unit in the HRB Clinical Research Facility, NUI Galway.  He has a strong publication record in the development and application of biostatistical theory in clinical trials, observational clinical research, Sports and Exercise Science and in the emerging field of Translational Statistics.  He is the Director of the MSc and PhD programs in Biostatistics, Co-Director of the MSc in Clinical Research and founder of the Summer School in Biostatistics, now in its 7th year.

Link to own Web page: http://www.maths.nuigalway.ie/~jnmaths/

Conferences/Workshops Co-organised

  • 21st International Workshop in Statistical Modelling, 2006.
  • 20th Conference on Applied Statistics in Ireland, 2004.
  • Advanced Programming in R, 2007.
  • Workshop on Meta Analysis, 2001.
  • Maximising Performance in Sport, NUI Galway, 2001.

Executive Committee Memberships

  • Statistical Modelling Society
  • Irish Statistical Association

Academic Awards

  1. Government of Ireland Travel Award, 2007.
  2. NUI Galway Millennium Fund Award, 2007.
  3. Fulbright Scholarship, 2005.
  4. Health Research Postgraduate Reward, 1995-1999
  5. Postgraduate Award, Department of Statistics, Glasgow University, 1995-1999.
  6. University College Cork Boole Prize in Mathematics, 1991.
Research Area:

His main areas of research in Biostatistics include design and analysis of clinical trials, statistical modelling, survival analysis, computational inference, functional data analysis and applications in Biostatistics and in Sports and Exercise science. He has co-authored over 40 peer-reviewed publications and a book entitled “Statistics for Sports and Exercise Science: a practical approach” (published by Pearson). He has three PhD students in Statistics, one MSc student in Biostatistics and three jointly supervised PhD students in Medicine. He has extensive teaching experience that includes delivery of courses in Probability Theory, Mathematical Statistics, Linear Modelling, ANOVA and Design of Experiments, Sampling Theory, Epidemiology and Biostatistics.

Current Projects:

Research Grant Awards (Principal Statistician)

1.       Dose Adjustment for Normal Eating (DAFNE)

Structured education programmes for patients with Type 1 diabetes are a common feature of care delivery in North America and many European countries. These programmes emphasise self-management skills training and encourage patient empowerment. One such programme, entitled Dose Adjustment for Normal Eating (or DAFNE), has been introduced to a number of diabetes centres in Ireland. It consists of 5 consecutive days of group education delivered by a team of trained educators comprising a specialist nurse, dietician and doctor. In collaboration with UK DAFNE colleagues, a research grant was obtained from the Health Research Board of Ireland as part of their Health Services Research and Development Awards 2005.  This grant supported a study to examine two different methods of follow-up of DAFNE graduates; a return to individual clinic visits (the current standard of care) versus group follow-up (the intervention arm of the study).

Funding awarded: €1.2 million over 5 years.

Principal Investigator: Dr Sean Dineen, Department of Medicine, National University of Ireland, Galway,

2.       Big Brother Big Sister

This is a major three year experimental study, undertaken by the Child and Family Research Centre at NUI, Galway, on the effectiveness of the Big Brother Big Sister mentoring programme for at-risk youth in the West of Ireland. The research has been commissioned by the programme provider Foroige and funded by the Atlantic Philanthropies Ireland and the One Foundation. 

Funding awarded: €0.5m over three years.

Principal Investigator:  Dr. John Canavan, Child and Family Research Centre, National University of Ireland, Galway,

3.         Dementia Reminiscence Education Programme for Staff (DARES)

The DARES study uses a mixed-method design, including a cluster randomised control trial, to test the impact of a structured staff education programme on dementia, incorporating reminiscence, on quality of life and levels of agitation of residents with dementia in long-stay care. The impact of the education programme on staff attitude towards residents with dementia and perceived care burden is also measured.

Funding awarded: HRB €300,000 over four years.

Principal Investigator:  Professor Kathy Murphy, School of Nursing & Midwifery, National University of Ireland, Galway; Dr Dympna Casey, School of Nursing & Midwifery, National University of Ireland, Galway.

4.         Pulmonary Rehabilitation In Nurse-led Community Environments (Prince)

Examining the impact of a pulmonary rehabilitation programme incorporating a behaviour change component for people with Chronic Obstructive Pulmonary Disease (COPD)

Funding awarded: HRB €652,079  over five years.

Principal Investigator:  Professor Kathy Murphy, School of Nursing & Midwifery, National University of Ireland, Galway; Dr Dympna Casey, School of Nursing & Midwifery, National University of Ireland, Galway.

5.         Secondary Prevention of Heart Disease in General Practice (SPHERE)

A six-year follow-up to the original SPHERE study which involved a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses.

Funding awarded: €1,140,517.

Principal Investigator:  Dr. Andrew Murphy, Department of General Practice, National University of Ireland, Galway.

6.         Chronic Disease Management: Innovations for patients, practitioners and policy ('The 3P Research Programme')

Funding awarded: €5,000,000

Principal Investigator:  Dr. Andrew Murphy, Department of General Practice, National University of Ireland, Galway.

7.         Assessing the prevalence, monitoring and management of chronic kidney disease n patients with cardiovascular disease compared with those without cardiovascular disease in the community.

Funding awarded: €10,000

Principal Investigator:  Dr. Liam Glynn Murphy, Department of General Practice, National University of Ireland, Galway.


Research Grant Awards (Principal Applicant)

  • NUI Galway, Visiting lecturers grant (€2,000) 2000.
  • NUI Galway, Millennium Research Grant (€2,500), 2002.
  • NUI Galway, Millennium Research Grant (€1,750), 2003
  • NUI Galway, Centre for Excellence in Learning and Teaching Grant for innovation in Teaching (€2,500), 2004.
  • Irish Research Council for Science, Engineering and Technology (IRCSET) Embark Initiative's Postgraduate Research Scholarship Scheme 2007 (€72,009)
  • Irish Research Council for Science, Engineering and Technology (IRCSET) Embark Initiative's Postgraduate Research Scholarship Scheme 2008 (€72,009)

Current Postgraduate Students:

  1. Alberto Alvarez: Extensions and Applications of Survival Trees in Medical Data
  2. Deirdre Wall: Integration of miRNA data in prognostic models for breast cancer
  3. Eoghan O'Brien: MSc Biostatistics (Research)

Previous Postgraduate Students:

  1. Andrew Simpkin: Estimating Derivative in Noisy Data with Biomedical Application (2010)
  2. Orla Doolin: MSc Biostatistics (2010)

 

List of Selected Publications:

Bentley D, Newell J, Bishop D. Incremental Exercise Test Design and Analysis: Implications for Performance Diagnostics in Endurance Athletes. Sports Medicine. 37(7):575-586, 2007.

Newell J, Higgins D, Madden N, Cruickshank J, Einbeck J, McMillan K, Macdonald R. Software for Calculating Blood Lactate Endurance Markers. Journal of Sports Sciences, October 2007; 25(12): 1403 – 1409.

Newell J, Kay J, Aitchison TC. (2006).  Survival Ratio Plots with Permutation Envelopes in Survival Data Problems. Computers in Biology and Medicine. May;36(5):526-41.

Newell J, McMillan K, Grant S,  Riach, I,  Henry, J, and  Macdonald R.(2006).  Using Variable Reduction Techniques and Tolerance Intervals to Summarise a Fitness Testing Battery in Soccer. Journal of Quantitative Analysis in Sport. Vol. 2: No. 4, Article 2.

Newell J, McMillan K, Grant S, McCabe G (2006). Using Functional Data Analysis to Summarise and Interpret Lactate Curves.  Computers in Biology and Medicine. Mar;36(3):262-75

Burden AD, Newell J (1999). Genetic and Environmental Influences in the Development of Multiple Primary Melanoma.  Archives of Dermatology, Vol 135, p261-265.

Kelleher C, Newell J, McHale E, et al (1998).  Incidence and Occupational Pattern of Leukaemias, Lymphomas and Testicular Cancers in Western Ireland over an 11 year period.  BMJ Journal of Epidemiology and Community Health. Vol 52, No 10, p651-656.

Clinical Research Manager

Veronica McInerney

The nurse manager, Veronica McInerney, holds a Masters Degree in Health Research and has over 20 years experience in nursing, 10 of those years dedicated specifically to research management. She has project managed over 75 clinical trials during that time. These studies range from translational research projects to phase 1, phase 2 and phase 3 studies and also a number of expanded access programs. Through her experience in the management of clinical trials and research studies, she has a positive track record in external audit by regulatory bodies. She has successfully led many inspections by the Irish Medicines Board and also has successfully led sponsor inspections by international study groups and pharmaceutical sponsors.

Veronica currently leads a growing team of specialist nurses who conduct trials in compliance with Good Clinical Practice, Medical Devices Standards and in adherence with relevant Irish and European regulations. Our nursing staff assists with all aspects of the research process including:

  • Coordination of research activity
  • Patient work-up and treatment
  • Procedures, sample handling and processing
  • Patient follow-up, clinical assessment
  • Data collection data entry and completion

The nursing group work very closely with the study management team and principle investigator to conduct the study in the most efficient way to achieve the best outcome whilst all the time demonstrably ensuring high standards and quality assurance.