Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP
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Staffing is as follows:
Study Nurses 1 Data Entry Clerk Pharmacy Staff Laboratory Staff Admin
4 (2 full time/ 2 1 0 0 3*
part time)
* 1 Manager (who is also one of the study nurses), 1 Assistant, 1 Financial Director.
The unit uses the hospital pharmacy in its conduct of clinical trials if necessary. Laboratory tests are
conducted at the hospital or private laboratories.
Quality control/ assurance procedures are based on detailed and extensive Standard Operating Procedures
and are compliant with ICH, Health Canada, and FDA Good Clinical Practice (GCP) guidelines.
All projects are approved by the REB prior to initiation and all research staff are trained appropriately in
clinical trials, GCP regulations and guidelines, and the SOPs. The Unit also participates in monitor and
study termination visits and audits.
Contact:
Breakwell, Lynn. RN. Tel: 604-587-3720. lynn.breakwell@fraserhealth.ca.
Fraser Health Critical Care Group
Critical Care research in Fraser Health is conducted at Surrey Memorial (SMH) and Royal Columbian
(RCH) Hospitals (http://research.fraserhealth.ca/clinical_trials/clinical_trials_research_groups/). The
focus of the research program is on contributing to publicly funded trials, [e.g. Thromboprophylaxis;
ARDS; Sedation management, Life support outcomes for Octogenarians; Ventilator Associated Pneumonia;
H1N1] largely in collaboration with the highly successful Canadian Critical Care Trials Group. Other
research includes industry funded studies [e.g. Sepsis; Surfactant in Acute Lung Injury; Novel Vasopressors]
and small investigator driven pilot studies [e.g. Topical antibiotics to reduce central line infections,
dosing of antibiotics in non dialysis dependent renal failure]. Industry-sponsored trials include Phases II
and III.
The key Principal Investigators are:
• Reynolds, Steven (Intensivist and ICU Research Director, Royal Columbian Hospital)
• Keenan, Sean.
Their details can be found in Appendix 6.
Contact:
Svetik, Miroslav. ICU RCH Research Coordinator. miroslav.svetik@fraserhealth.ca.
Mans, Sheilagh. ICU SMH Research Coordinator. Sheilagh.Mans@fraserhealth.ca.
Multiple Sclerosis Clinic
Based at Burnaby Hospital, the Fraser Health Multiple Sclerosis clinic provides a comprehensive, community
based clinic to the Fraser Health region (http://research.fraserhealth.ca/clinical_trials/clinical_trials_research_groups/).
The clinic has 13 multidisciplinary team members (4 neurologists, urologist,
neuro-ophthalmologist, psychiatrist, rehab medicine, MS certified nurse, physical therapist, occupa-