NIHR Manchester University NHS Foundation Trust UKCRF

The UK Clinical Research Facility Network (UKCRFN) connects CRFs (NIHR and non-NIHR) to benefit patients across the UK/Ireland.

By sharing expertise and resources, delivering networked experimental medicine (EM) and early-phase trials, UKCRFN is unique with a track record of successful delivery of objectives at pace.

Established in 2008 and successfully delivered from Manchester University Hospitals NHS Foundation Trust, it will continue to collaborate with CRFs and other EM infrastructure including: Experimental Cancer Medicine Centres (ECMCs); Biomedical Research Centres (BRCs); Translational Research Collaborations (TRCs); and, Advanced Therapy (ATIMP) Accelerators across the UK/Ireland.

We will continue developing, sharing and implementing operational excellence, to further enhance performance in delivering early phase and higher risk research across an integrated platform of CRFs.

Working closely with the National Office for Clinical Research Infrastructure (NOCRI), ECMC/BRC/TRC, NIHR Clinical Research Network Coordinating Centre (CRNCC), industry and charities, our vision is to build on sustained success by: Providing ongoing/unparalleled expertise in CRF operations Helping Department of Health & Social Care (DHSC) and NIHR to deliver the UK Life Sciences/Clinical Research Delivery Visions.

This funding cycle involves building a world-leading cohesive EM ecosystem, ensuring UK/Ireland researchers and industry can deliver EM research where geographically required.

Building on previously successful themes, key objectives are embedded in four Work Packages (WP) with sub-strategies, detailed in section 5 (Strategic and Delivery Plan).

We concentrate operational, strategic and workforce into these and cross-cut with public and patient involvement, engagement and participation (PPI/E/P); equality, diversity and inclusion (EDI); marketing/communications; and data/metrics.

We will work with UK Government departments, Association of British Pharmaceutical Industry (ABPI), Association of Medical Research Charities (AMRC) and pharma to significantly build previous network industry/charity collaborations in WP2.

Delivered by CRFs across the UK/Ireland, UKCRFN s enhanced programme will evolve, and complement, functions led by other parts of NIHR infrastructure.

We will continue curating what has been delivered over the last 22-years, maintaining knowledge-management and ensuring succession-planning.

We will achieve our objectives by: Expanding/refreshing Strategic Advisory Board (SAB) for governance/strategy Refreshing Senior Management Team (SMT) and structures Creating four new WP Leads, Deputies, Workstream/Group Leads and Directorial links - overseeing the delivery of key objectives Establishing a named CRF Director links to ECMC, BRC/TRCs, CRNCC Continued work with the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to ensure CRF/NHS minimum governance standards for phase-1 trials Working with NIHR, ECMCs and ATIMP Accelerators to ensure costing for Phase I and ATIMP trials is fully accommodated within the framework of the NIHR iCT (Interactive Costing Tool) Working as part of a unified clinical research delivery system including the CRNCC, Hospital R&D Departments via UK R&D Leadership (UKRD) and the University Hospital Association (UHA( R&D Directors Groups Providing value-for-money (VFM) Succession planning for Directors, SMT and WP Leads UKCRFN works and has a track record of evolving to meet both current and future challenges, and this One CRF bid reflects that attribute.