Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

APPENDIX 11. Independent Clinical Trials Service Companies (cont’d)
Types of Clients Regulatory
Qualifications
Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and
Type of Staffing
304
Scientific Advisory
Committee providing
expert advice
on all relevant
aspects of the
program, including
study protocol
and analytical
plan, selection
of participating
centres, choice and
use of outcome
measures, review
of the analysis
plan, and preparation,
submission
and authorship of
scientific communication
outputs.
Data or Safety
Review Committee:
consisting of medical
and statistical
experts in the
relevant field
ervices.
• Real-Time Data Management: Internet-based research networks
enable real-time electronic data capture- recording of
clinical data, with independent but simultaneous subjectbased
reporting of health status and resource utilization.
• ClinStream also facilitates an electronic clinical research
system linking research partners in over 40 countries with
speed, security and accuracy, and enables the seamless
integration of clinical, laboratory, health outcomes and
economic data for comprehensive clinical evaluation of
treatment effectiveness and value.
• Pharmacovigilance: safety reports are reviewed by Medical
Monitors, then processed, databased and archived by
Safety Specialists, following which critical safety information
is forwarded to Regulatory Authorities via CIOMS or
MedWatch forms. Syreon provides 24-hour, pager-based
on-call Medical monitoring services where required. Serious
adverse events are assessed for expectedness, and to ensure
adherence to regulatory reporting timelines.
BRITISH COLUMBIA