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Our expertise

We have world-leading experimental medicine and complex early phase trial expertise. We hold vast experience gained from over 800 first-in-human, phase I and phase IIa studies in the last 10 years. Our facility fully integrates 2,000m2 of trial infrastructure into the heart of one of the UK's largest acute teaching hospitals.

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Our CRF location enables emergency cover from University Hospital Southampton including emergency response teams and its intensive care units (ICUs). We have facilities for children and adults in both the CRF and wider hospital footprint.

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We enable researchers and external partners to deliver trials on time and on target. Over 900 CRF and partnership staff have been trained to work on phase I trials. Five Southampton senior researchers are accredited MHRA first-in-human investigators. We connect partners with expert Principal Investigators for commercial and non-commercial trials.

  • Southampton respiratory research is a key part of Synairgen’s development of interferon beta as an acute treatment for COVID-19, following over 10 years of trials in the CRF.

  • Our HARE-40 trial, run by the Southampton Clinical Trials Unit, is looking at whether an RNA vaccine could be an alternative treatment for people with HPV driven cancers such as head and neck cancer.

  • When the pandemic struck, we were the first site outside Oxford to enrol in the phase I Oxford vaccine trial. We recruited all participants aged over 70 to the phase II trial. By the end of 2021, two billion doses of this vaccine will have been administered globally.

  • Our world-first trials have shown that controlled infection through nose drops of modified 'friendly' bacteria protect against meningitis.

  • Our support for the MAVIDOS TRIAL delivered evidence for vitamin D supplements in pregnancy, showing greater bone mass in winter babies born to mothers receiving vitamin D.

  • We’ve contributed to evidence shaping preconception and pregnancy health policy, through delivery of the Southampton Women’s Survey. That’s tracked 12,583 women and their 3,158 children from 1998, underpinning key studies of lifelong impacts for children of developmental influences.

Our expertise drives ground-breaking studies that are shaping the next generation of healthcare:

National leadership
 

Our team are expert in the feasibility, costing and coordination of research. Project Management for CRFs was developed in Southampton. Our expertise has been shared for over a decade in the UKCRF Network.

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Southampton consistently demonstrates national leadership in the standards and governance of research. We co-led development of the UK Clinical Research Facility (UKCRF) Network framework to ensure minimum standards for highest risk phase I trials in all CRFs and NHS Trusts. We then piloted the use of this framework for COVID-19 vaccines and therapeutics trials.

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We have trained all the UK Cystic Fibrosis Trust phase I clinical trial accelerator (CTAP) sites on essential phase I oversight and governance for patient safety. Using this expertise, we work with companies to apply for phase I investigator and commercially sponsored trials.

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An overview
 

In summary, NIHR Southampton Clinical Research Facility expertise contains:

  • First-in-human (FIH) and phase I experience

  • Facilities developed for early phase research

  • Early phase recruitment and trial management expertise

  • Close proximity to emergency care (ICU, emergency response teams from NHS acute trust)

  • MHRA First in Human investigators

  • An early phase safety committee

  • ATIMP expertise

  • Child and adult facilities

  • Investigators expert in all medical and surgical specialities

  • Early phase trained workforce

  • Regular emergency scenario training

  • Early phase QA/QC experience

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