GlaxoSmithKline Clinical Unit Cambridge (CUC)

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Clinical Unit Cambridge:

CUC specialises in early stage clinical studies for potential new medicines across a broad range of therapeutic areas

The unit has specialist Phase 1 accreditation by the Medicines and Healthcare products Regulatory Agency (MHRA)

• We are licensed to conduct studies in human volunteers

• We are able to conduct studies where a new medicine is given for the first time in humans

• We concentrate on small studies with: –Intensive monitoring, addressing initial safety and tolerability

readouts –Experimental biomarker assessments for early indicators of

mechanism of drug action

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Clinical Unit Cambridge:Facilities

A GSK run hospital based clinical unit :

• Recruitment database of >3500 Healthy Volunteers and Patients

• 24 general beds with continuous physiological monitoring and real time electronic data capture

• Specialist study rooms

• Sample handling and Experimental Medicine laboratories

• Access controlled Pharmacy used for storage, assembly and administration activities for all drug products IMP’s and non IMP’s

• Dedicated team of study and recruitment coordinators supported by approx 90 Qualified bank/ contract staff

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How studies are conducted by CUC

• Partner with GSK therapeutic areas in the development and operational practicalities of GSK studies

• Collaborate with Academic/NHS partners in the development and operational practicalities of GSK studies

• Recruit healthy volunteers and patients - ensuring full consent and inclusion/exclusion screening

• Set up and run clinical phase of study ensuring– regulatory requirements are met GCP,GMP, GLP– ethical requirements are met– NHS Trust R&D requirements are met– medical Governance & wellbeing of subjects is met– data integrity

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Support

• Why are we seeking support from GP practices– To secure support for patient identification

• What support are we needing– Database search using basic criteria and sending letters of invitation to those who may be suitable

to participate

• What is in it for the Practice– Recognition of research activity by the NIHR

– Able to offer patients the choice to participate in the development of novel treatments

Thank you