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How ABMU works with How ABMU works with Industry

How ABMU works with 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

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How ABMU works with How ABMU works with Industry

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  1. How ABMU works with How ABMU works with Industry • Jemma Hughes • R&D Manager • ABMU Health Board

  2. 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.

  3. 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

  4. 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

  5. Clinical, Managerial & Administrative support • Clinical Research Nurse support • Management/Administrative support to facilitate • Feasibility assessment • Departmental Negotiations • Costings • SSI completion & submission

  6. 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.

  7. Thank you • abm.rd@wales.nhs.uk • 01792 704056

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