Meet our team
The NHS Blood and Transplant (NHSBT) Clinical Trials Unit (CTU) provides a skilled and experienced team who are committed to delivering expert support and efficient trial management.
The CTU is headed-up by Rachel Johnson, Assistant Director of Statistics and Clinical Studies.
Our staff are specialists, whether within data management, statistics or clinical operations.
For enquires please contact us.
Our Statistics Team
Our statisticians provide a full statistical service throughout the life cycle of the clinical trial. From the outset, we can advise on trial design and sample size requirements, and contribute to the production of trial protocols and funding applications. Our statistics team, based in Bristol, will also work with you to develop plans for interim analyses and develop the analysis plan for the final dataset using the latest techniques to make best use of the data. After the data has been locked and the analysis performed, we can assist with final trial reports and papers for publication.
Elinor is a senior statistician in the Statistics and Clinical Studies department and a PhD student in statistics at the School of Social and Community Medicine, University of Bristol. Her current research focuses on modelling patient outcomes following haematopoietic stem cell transplantation. Elinor is the trial statistician for E-FIT1 and TREATT. She also works on studies in transfusion medicine and stem cells.
Tel: 01179 757474
Cara is a Mathematics graduate from the University of Bristol and joined the Statistics and Clinical Studies team in August 2007. She subsequently gained an MSc with distinction in Statistics and Management Science from the University of the West of England. Cara is the Senior Statistician providing statistical support for the design and analysis of clinical trials.
Tel: 01179 757432
Alex has an MSc in Medical Statistics from the University of Leicester and joined NHSBT in 2015, initially working at the British Bone Marrow Registry. She is currently a Senior Statistician in the Statistics and Clinical Studies team, and is involved in the DRIVE and REDJUVENATE clinical trials. Outside the CTU, Alex also works on projects in haematopoietic stem cell transplantation.
Tel: 01173 227280
Laura undertook a placement year at NHS Blood and Transplant (NHSBT) during her undergraduate degree and subsequently gained an MSc with distinction in Statistics with Applications in Medicine from the University of Southampton. She returned to NHSBT in 2011 and is now a senior statistician providing statistical expertise in the design and analysis of clinical trials. Laura is the trial statistician for HLA-Epitope, PlaNeT-2, EVNP DCD kidney and REDDS; and is the independent statistician for TREATT. Prior to working full time in clinical trials, she undertook extensive analysis of kidney transplant data from the UK Transplant Registry, held by NHSBT.
Tel: 01179 757431
Matthew has a PhD in Applied Mathematics from the Imperial College London and has worked at NHS Blood and Transplant since 2013. Matthew is a Senior Statistician and is the trial statistician for REAL. Outside of his work on clinical trials, he is also the statistician for the Blood and Transplant Research Unit (BTRU) in Organ Donation and Transplantation and also supports studies in kidney transplantation.
Tel: 01179 757518
Helen has an MSc in Medical Statistics with distinction from the University of Leicester and has worked at NHS Blood and Transplant since 2004. Helen is a Principal Statistician and co-ordinates all aspects of statistical support for the Clinical Trials Unit. Helen worked on the CRYOSTAT feasibility trial, and is the trial statistician for CRYOSTAT-2 and RESTORE. She is also working on the design of other forthcoming trials. Helen also has experience serving as the independent statistician on a Data Monitoring Committee.
Tel: 01179 757485
Agne has an MSc with distinction in Statistics with Applications in Medicine from the University of Southampton. Agne joined the Statistics and Clinical Studies team in October 2015 and as part of her role provides statistical support for the design and analysis of clinical trials. She supports the EFIT1 and REDDS clinical trials, and also conducts analyses of liver transplantation data.
Tel: 01179 757489
Our Data Management Team
Our Data Management team provides overall data management support; from data capture form and database design, to data entry, query production and resolution, and final data cleaning. An industry standard clinical trial database management software system – MACROTM - is used for the design, management and capture of clinical trial data for all our randomised clinical trials, and supports data entry via a web browser.
Clinical Data Services Manager
Renate has a BSc (Hons) in Biology from Portsmouth. She has over 12 years experience in data management gained in the pharmaceutical industry, the majority of which was accomplished working for a Clinical Research Organisation. She started her career working in the Haematology Lab of the local hospital and during this time completed an MSc in Biomedical Science, specialising in Haematology. Renate joined our CTU as a Senior Clinical Data Manager in September 2010, taking on the Lead Data Manager role for the TAPS and PRISM trials until completion, and then proceeded to work on several more trials including PlaNeT-2, HLA-Epitope, E-FIT1, REDDS and Trigger, from the CRF and database design stage onwards. Renate has been the Clinical Data Services Manager since November 2015 and now manages the Data Management Team and the Clinical Database Management Systems.
Tel: 07471 147968
Trials Support Officer
Val has both an administrative and clinical background which began in Higher Education at Anglia Ruskin University and The School of Clinical Medicine, Cambridge. She went on to train as an Assistant Practitioner in Breast Imaging, working at The West Suffolk Hospital and The Rosie, Addenbrooke's Hospital for the NHS Breast Screening Programme. Prior to joining CTU, Val worked as a Medical Laboratory Assistant at The Pathology Partnership’. Val joined the Data Management Team in CTU in March 2014 working on the PlaNeT-2 Trial.
Tel: 01223 588188
Junior Clinical Data Manager
Siobhan joined the CTU in May 2017 after completing a Physiology degree at the University of Nottingham. She is currently working on several Electronic Data Capture studies, performing data clean-up and providing training and support to sites.
Tel: 01223 588924
Junior Clinical Data Manager
Rupa joined NHSBT CTU in April 2017, primarily working on the CRYOSTAT-2 trial as part of the data management team. She is currently working on building the trial database and will be involved in all aspects of processing the trial data.
Our Clinical Operations Team
The Clinical Operations team work with investigators to ensure that the trial is successful. A Clinical Operations Manager will be assigned to your trial at the beginning of our involvement and will remain with the trial until completion. They will oversee the work of the trial manager, manage the budget and timelines and liaise with data management and statistical staff as required.
Head of Operations
Alison Graduated from University College Cardiff with an honours degree in Biochemistry before training as a general nurse and then a midwife. Alison has over 15 years experience of clinical research in various settings, starting off as a research nurse, then moving into industry, where she worked for a biotechnology company and for Clinical Research Organisations, gaining experience of managing international trials in various therapeutic areas. Along the way she gained an MSc in Clinical Research. Alison has worked for NHSBT CTU since April 2010. She started as a Clinical Operations Manager, and has been Head of Operations since January 2013. Alison is responsible for the development and implementation of the CTUs programme of clinical research and overseeing the operational aspects of trial management, including ensuring compliance with all relevant guidelines and regulations.
Tel: 07889 304290
Clinical Operations Manager
Claire is one of our Clinical Operations Managers (COM). She is a nursing graduate who specialised in Haematology Oncology Nursing. She worked as a Haematology Research Nurse involved with phase II and III multicentre trials in the cancer field before moving to the then National Blood Service as a Research Nurse co-ordinating the Safe Transfusion project. This work involved evaluating a barcode patient identification system which became an international exemplar project for improving patient safety. Claire first joined the CTU as a Research Nurse/Trial Co-ordinator in 2004, working primarily on the successful TOPPS trial, a now published RCT that looked at platelet use in the malignant haematology patient population. In her current role as COM Claire is responsible for providing team leadership to support the expanding clinical trials portfolio. She completed an MSc in Clinical Research in 2016.
Tel: 07764 280855
Claire holds a PgDip in Clinical Trials from the London School of Hygiene and Tropical Medicine. Claire joined NHSBT CTU in 2014, as a Trial Manager with 10 years experience in managing multi-centre cardiovascular and respiratory studies, specifically in CTIMP trials. As a Trial Manager, Claire will undertake all aspects of study management including protocol development, site feasibility and set up, training, IMP management, monitoring and close out.
Tel: 07823 351738
Senior Research Project Lead
Nina has more than 16 years experience within the clinical research field, ten of which were spent co-coordinating and running studies for the Cambridge Wellcome Trust Clinical Research Facility. Nina has been trial manager for the HPA-1a study and the PROMPT study, more recently she was clinical lead on a platelet recovery study following donation. She is now one of the key people setting up the RESTORE trial. In her spare time Nina is team manager for the Cambridge Transplant Games Team, promoting organ donation and helping others through sport to celebrate their Gift of Life.
Tel: 07590 352340
Trial Support Officer
Chloe has a clinical background in midwifery and varied project management experience. She joined CTU in the role of the administrator for the InCiTe (Case-Control Study of Intra-Cranial Haemorrhage in Thrombocytopenic Haematology Patients) and is now providing administrative support for the TREATT (Trial to Evaluate Tranexamic Acid Therapy in Thrombocytopenia) trial.
Tel: 07808 906305
Emma graduated from King's College London with an Honours degree in Biomedical Science. She started working in clinical research at Luton and Dunstable Hospital in 2012, and was involved in cancer trial co-ordination and set-up. Emma’s clinical experience includes discussing trials with patients, obtaining informed consent and performing trial assessments. Emma joined NHSBT CTU in 2015 as a Trial Manager – and is currently working on DRIVE, PITHIA and HLA-Epitope.
Tel: 07471 147868
Clinical Operations Manager
Ana holds a PhD in neurodevelopment from University College London and a PgDip in Clinical Trials. She became involved in clinical trials in 2007 after previous experience in the stem-cell technologies for novel therapies at ReNeuron and pre-clinical research at GlaxoSmithKline. Initially Ana worked for the Haematology Trials Team at the Cambridge Cancer Trials Centre, coordinating a wide portfolio of commercial and non commercial phase I to phase III haemato-oncology clinical trials. Ana joined NHSBT in 2010 and was appointed as Clinical Operations Manager in September 2013. She is responsible for providing project management support for a portfolio of clinical trials.
Tel: 07889 304288
Trial Manager/Senior Research Nurse
Gillian is a registered nurse with a degree in Health Care Studies and a Diploma in Critical Care. Her clinical background is in the specialities of intensive care, intravenous therapy and blood transfusion. She joined NHSBT in 2008 to work as a research nurse on the TOPPS Trial and later became the trial manager. Gillian has worked as a research nurse on the granulocytes in neutropenia (GIN) and Risk factors for haemorrhage in thrombocytopenic haematology patients (Athena) studies. Gillian set up the Red Blood Cell Transfusion Thresholds and Quality of Life in Myelodysplastic Syndromes (REDDS) trial, was trial manager for an intensive care study of coagulopathy (ISOC-2) and is now managing the TREATT trial.
Tel: 07590 353091
Anna’s background is in Medical Microbiology where she worked in clinical trials via a central laboratory; processing samples for a very large trial looking at antibiotic resistance in respiratory infections. She left her lab days behind her to work for Sanofi-Aventis and then Roche, as a Clinical Research Associate. When the Clinical Research Networks expanded, she joined the Kent & Medway CLRN as their Industry Manager, looking after their portfolio of commercial trials. Anna then moved to work at Addenbrooke's Hospital mainly supporting Neurosciences research. She spent some time embedded in the Neurosurgery department, and then did a lot of work in paediatric epilepsy and Parkinson's Disease. Since joining the NHSBT Clinical Trials Unit in November last year, Anna has been working on PlaNeT-2.
Tel: 07392 139868
Heather is a registered sick children’s & general nurse with over 30 years experience in paediatric nursing at; Great Ormond Street Hospital, London, Queens Medical Centre, Nottingham and Addenbrooke’s Hospital, Cambridge. Heather has worked as a research nurse/trial coordinator in clinical research in the Haematology Department, University of Cambridge from 2002 , moving to the Clinical Trials Unit of NHSBT in 2006 to work on various non-commercial trials. More recently Heather has been working as the trial manager for several feasibility studies; REDDS, REAL and RePAST. These are studies in transfusion threshold strategies and patient quality of life in Myelodysplastic Syndromes and Acute Myeloid Leukaemia.
Tel: 07471 147896
Clinical Trial Manager
Samaher joined the CTU in 2017 as Clinical Trial Manager for a trial to improve outcomes for renal transplant patients (ITOPS). She is a registered nurse and has worked in adult and paediatric cardiac surgery intensive care. She completed a MSc in advanced nursing practice at Nottingham University in 2005, and a PhD in public health research policy awarded from the University of Central Lancashire in 2016. Samaher has been involved in clinical research since 2007, having worked as a research nurse for several medical and surgical phase II and III oncology and haematology clinical trials in Leeds and Lancaster. She has also been trial manager and research nurse for a sleep study at Oxford University Hospitals.
Tel: 07392 139747
After studying for a degree in London, Karen undertook nurse training at University College Hospital and subsequently worked in a variety of clinical areas, before becoming a midwife. She later studied for the Common Professional Entrance to Law and undertook the Legal Practice Course, gaining the Law Society Award. On returning to the NHS, Karen worked in clinical audit, and later Patient Safety, concentrating on Women and Children’s services. She has co-ordinated the PLANET-2 Study in neonatal medicine for the past few years.
Tel: 07966 223752
Jo has previously worked as a Trial Manager in the Cardiovascular Epidemiology Unit at the Department of Public Health and Primary Care (University of Cambridge) and in the Faculty of Medicine & Health Sciences at the University of East Anglia. She has experience of working in varying roles in Universities and the NHS, most recently as Research & Development Co-ordinator at the James Paget University Hospital. Her research interests include Trauma, Critical Care, Cardiovascular and Mental Health. Jo is the Trial Co-ordinator for the CRYOSTAT-2 study, looking at the effect of early cryoprecipitate on mortality in patients with major haemorrhage.
Tel: 07764 280606
Clinical Trial Manager
Kiri joined the CTU in 2017 as clinical trial manager for the CRYOSTAT-2 trial. This multi-centre, international trial is investigating whether earlier administration of a blood product called Cryoprecipitate reduces mortality in major trauma patients who are experiencing major haemorrhage. Kiri's background is in psychology trials and she holds a PhD in Psychology and a Masters in Research Methods in Cognitive Neuropsychology. Kiri has worked in mental health since 2004 and in research since 2008, working on numerous studies, including those in schizophrenia, depression, mental health decision making and mentalization based treatment for fostered children.
Tel: 01223 588016
Our Administration Team
The CTU is supported by our business manager together with a trial administrator and our medical business administration apprentice. They ensure that the unit is running smoothly.
Apprentice Business Administrator
Chloe joined NHSBT CTU in January 2017, taking on the role of Apprentice Clinical Business Administrator. Just some of what the job entails is organising and booking meetings, sorting peoples travel arrangements and archiving important clinical trial documents. The role is also about helping the Trial managers with the admin side of some trials, including Planet-2, ProGrES and CRYOSTAT-2. After the apprenticeship is completed, Chloe is hoping to develop further into a career within NHSBT.
Tel: 01223 580175
CTU Business Manager
Jayne is usually the first point of contact for CTU, and she will be able to direct your call to the relevant person. She provides administrative support to the team with organisation of meetings, venue bookings and associated travel. Her knowledge includes HR and financial support for the Unit, ethical applications, site legal agreements, co-ordination of research trial activities, maintaining the Quality Management System documentation and training, as well as having primary responsibility for archiving.
Tel: 01223 588088
Quality Assurance Manager
Jose graduated from University of Coimbra (Portugal) with a PharmD in Pharmaceutical Sciences. He also holds a Master Degree in Quality Control from University of Porto (Portugal). Jose worked in Regulatory Affairs and Quality Assurance in the pharmaceutical industry sector, and as a Quality Manager in a Cord Blood Bank. He recently joined the NHSBT Quality Assurance department.
Tel: 01223 588182