How ABMU works with Industry
Jemma Hughes
R&D Manager
ABMU Health Board
Research is a NHS Target
• Research is part of the business of the NHS
• Recognised in Wales through the implementation of a target on
all Health Boards & NHS Trusts to double the number of
patients in Clinical Trials within 5 years.
• Importance role of Industry to offer patients access to new
treatments & contribute to meeting this new target.
About ABMU Health Board
• ABMU provides primary & integrated secondary care services
for the region of Swansea, Bridgend & Neath Port Talbot,
covering the whole of Swansea to Cardiff for Learning
Disabilities, the whole of South Wales for Forensic Mental
Health & providing Burns &Plastic surgery services for all of
Wales & South West England.
• 4 Acute Hospitals
• 77 GP Practices
How ABMU is structured to support R&D
• Central R&D dept responsible for Health Board approval across Primary
& Secondary Care
• 3 dedicated Research Clinical Support teams offering clinical &
administrative support to trials
• Joint Clinical Research Facility (JCRF) part of ILS2, team of
specialist Research Nurses supporting clinicians within specialist
facilities in Morriston Hospital & ILS2
• Cancer Institute at Singleton Hospital hosts the Oncology Trials Unit
with a team of Cancer specialist research nurses
• NISCHR South West Wales Research Professional Network hold
Letters of Access with ABMU to support a list of NISCHR portfolio
studies
• Preferred site status with Novo Nordisk, Lilly, Quintiles
Clinical, Managerial & Administrative support
• Clinical Research Nurse support
• Management/Administrative support to facilitate
• Feasibility assessment
• Departmental Negotiations
• Costings
• SSI completion & submission
Governance Review of Industry studies
•
Contract reviewed by R&D prior to full submission.
•
No central review Committee, all departmental negotiations are agreed during SSI
completion.
•
No duplication of scientific review.
•
Global Governance checks undertaken by NISCHR PCU, local governance checks
undertaken by ABMU R&D includes verification of SSI detail against protocol, suitability
of local team & facilities, costings verification.
•
Quick approvals - due to prior contract review & knowledge that all departments have
reviewed protocol & agreed prior to submission, we do not repeat protocol review - we
verify SSI detail to ensure all activity has been captured & appropriately agreed.
•
Same approach to multinational pharma, CROs, device companies.
•
For SMEs, we happily have early discussions to offer our expertise & advice on
applicable regulations & approvals which may be required.
Thank you
abm.rd@wales.nhs.uk
01792 704056