GlaxoSmithKline Clinical Unit Cambridge (CUC)
2
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
3
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
4
5
6
7
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
8
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