National Institute for Health Research UCLH Clinical Research Facility

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Services offered by our clinical research facility

Our clinical research facility (CRF) offers a wide range of services for carrying out commercial and non-commercial studies:

 

  • Setting up new trials – we have an in-house trial co-ordination team who can assist with:

    • facilitating contract and costing negotiations with commercial sponsors
    • contributing to non-commercial grant applications
    • working collaboratively with UCLH service-support departments (e.g. pharmacy, imaging, pathology) as required
    • assisting with study documentation development and gaining ethical approval
    • co-ordinating submission to internal governance committee(s)
    • supporting researchers with expressions of interest to trial sponsors

 

  • Trial oversight and management – ensuring that trials are implemented to time and target, at the highest regulatory standards and in accordance with GCP.

 

  • Nursing and clinical expertise and support – the CRF team includes research nurses and physicians that can provide clinical support including:
    • informed consent, assessments of adverse events, management of medical emergencies, physical examination
    • blood and PK sampling, IMP administration, vital signs, ECG, phlebotomy
    • lumbar punctures/CSF sample collection, intrathecal dosing, neurological examination and psychometric/cognitive assessments for neurology studies

 

  • Data management - our team of in-house Data Managers and Data Administrators are experienced in data collection, completion of Case Report Forms and source data verification, and can accommodate on-site monitoring visits.

 

  • Quality assurance and risk assessments – our quality staff oversee the adherence of CRF trials to Standard Operating Procedures, GCP and relevant regulatory standards. We regularly undertake quality control checks and internal audits to ensure we are working to best practice at all times. Phase I trials are subject to an in-depth risk assessment.

 

  • Laboratory – Support includes: