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The Royal Liverpool University Hospital Becomes First National Health Service Facility in England to Achieve the Highest Level of Accreditation for "First in Human" Clinical Trials


6/27/2013 8:22:00 AM

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LIVERPOOL, ENGLAND, 27 June, 201: The clinical research unit (CRU) at the Royal -- the Covance-Royal Liverpool University Hospital Clinical Research Unit -- has become the first NHS (National Health Service) facility in England to be granted MHRA (Medicines and Healthcare products Regulatory Agency) standard and supplementary Phase I Accreditation.

The accreditation means the Royal has the first NHS clinical research unit in England that meets the high standards required for early clinical trials. This is where drugs or other treatments are tested on humans for the first time as part of tightly controlled research projects.

MHRA Phase 1 Accreditation will allow the Trust to perform clinical trials in patients with some of the newest treatments under evaluation, to some of the most rigorous set of standards in the world. It will help provide patients with greater access to the very latest drugs and technologies and will bring economic benefits to the city of Liverpool as a centre for global healthcare research.

The MHRA Phase I Accreditation scheme was introduced to improve the safety of clinical research volunteers and assesses the capability of the clinical research unit based on facilities, procedures, training and experience of staff. This accreditation will allow the Royal, together with the University of Liverpool, the Liverpool School of Tropical Medicine and six other local NHS Trusts that comprise Liverpool Health Partners (LHP), to be at the forefront of clinical developments and drug trials to prevent illnesses, provide faster diagnoses and find new treatments. LHP will make Liverpool a centre for clinical research and excellence, to ensure the benefits of medical research breakthroughs are directly passed onto patients in the region.

Co-director of the Clinical Research Unit, Dr. Amitava Ganguli said, "We are very proud to achieve MHRA Phase I Accreditation. This success has been a long time in coming and reflects the commitment and hard work of everyone involved in achieving this important standard. MHRA Phase I Accreditation gives additional reassurance and confidence that the Clinical Research Unit meets the highest clinical research standards in a unit that is fully supported by onsite NHS hospital facilities.”

Co-director of the Clinical Research Unit Dr Richard Fitzgerald said, “This will give local patients the opportunity to take part in clinical trials here at the Royal, using the very latest drugs and other treatments, as part of studies that will meet the highest standards within the safest environment. The Covance-Royal Liverpool University Hospital Clinical Research Unit together with its academic leads will be available for researchers across the Liverpool Health Partners for use in early phase clinical research.”

Royal chief executive Aidan Kehoe said, “This is excellent news for the Trust and our future plans to create the Liverpool BioCampus as a world leading centre in life sciences. Having MHRA Phase 1 Accreditation means we can begin to work towards making Liverpool a hub for world class research that will help us improve healthcare for patients in Liverpool and beyond.”

Earlier this year, the Royal announced a five-year exclusive agreement with Covance, a leading drug development services company, to work together in conducting early clinical trials at the Royal Liverpool University Hospital on behalf of biotechnology and pharmaceutical companies.

Rob Aspbury, Vice President and General Manager, Global Clinical Pharmacology Services at Covance said, “Covance is focused on delivering the highest levels of patient safety and data quality in research conducted on behalf of biopharmaceutical clients. The Royal Liverpool University Hospital shares this same focus on patients. The MHRA Accreditation will ensure our work continues meet the industry’s highest safety standards.”

For more information please contact 0151 706 5584/ 4286.

About the MHRA and Phase 1 Accreditation

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The Phase 1 accreditation process provides clinical trial volunteers and sponsors with confidence that research facilities and studies meet the industry’s highest safety standards. The process includes formal routine inspections that provide additional scope and depth to existing procedures for good clinical practice. MHRA Phase I Accreditation was introduced to improve the safety of clinical research volunteers and assesses the capability of the clinical research unit based on facilities, procedures, training and experience of staff.

About the NHS Trust

The Royal Liverpool and Broadgreen University Hospitals NHS Trust is one of the largest and busiest hospital trusts in the North of England, with an annual budget exceeding £400 million. It delivers services across two sites and three hospitals, the Royal Liverpool University Hospital, Broadgreen Hospital and Liverpool University Dental Hospital, and employs more than 5,500 people. The Royal has around 170 researchers currently working on over 450 studies. Each year the Trust sees more than half a million people in its outpatient department and deals with around 150,000 emergency patients and day case admissions. It is one of the top teaching trusts in the UK with well-established links to the University of Liverpool, Liverpool John Moores University and international institutions. In 2013 work will begin on a new £450 million state of the art Royal Liverpool University Hospital. To find out more about the Trust, visit www.rlbuht.nhs.uk.

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