NHS logoNewcastle Clinical Trials Unit


Newcastle Clinical Trials UnitNewcastle Clinical Trials Unit (NCTU) is a UK CRC registered trials unit. Our staff members include trial managers, data managers and statisticians, and through our position in the Institute of Health and Society (IHS), we can provide access to expertise in health economics and qualitative methods.

Services Offered

Clinical Research Platform logoIn conjunction with the Newcastle Biomedicine Clinical Research Platforms, the NIHR Research Design Service North East, and IHS colleagues, NCTU provides a ‘one stop shop’ for investigators planning, designing, conducting and analysing trials and high quality clinical research studies.

More specifically, the NCTU provides support:

  • in the development phase of high-quality clinical trials of the efficacy, effectiveness and efficiency of therapeutic and service level interventions
  • in their subsequent management and monitoring
  • in their analysis, interpretation and reporting

In respect of trial conduct and management, the focus of NCTU is on sponsor-level activities and overall project management; conduct and management of site-level activities is the remit of other Newcastle Biomedicine Clinical Research Platforms.

NCTU is able and willing to provide support to a wide range of types of trial, including Phase III and IV pharmaceutical trials, device trials and surgical trials, as well as those of service organisation & delivery, and of complex interventions aimed at behaviour change amongst professionals, patients and members of the public. In collaboration with the colleagues in the other Newcastle Biomedicine Clinical Research Platforms, we are also developing capacity and expertise in early phase trials (in particular Phase II). We support both single and multi-centre trials.

UKCRC Registered logoNCTU’s main market is university and NHS based investigators conducting non-commercial trials, funded by research councils, the National Institute of Health Research and charities, as well as investigator-initiated industry-supported studies. Our services in respect of preparation of applications for ethical, regulatory and R&D approvals and site monitoring are also available to commercial companies.

In addition to clinical trials, NCTU supports studies employing other research methods in preparation for the design and conduct of a future trial, for example, systematic reviews, feasibility and pilot studies, and the development and validation of patient reported outcome measures, as well as methodological studies relating to trial design, conduct and data interpretation.

Specialist Services

  • Support of regulatory authority applications
  • Support of main REC applications
  • Support of central R&D applications
  • Central and site monitoring
  • Clinical trial design
  • Power calculations
  • Statistical analyses

Further information:

  • Contact: Professor Elaine McColl
  • E-mail: e.mccoll@ncl.ac.uk
  • Telephone: +44 (0)191 222 7260