Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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304 BRITISH COLUMBIA APPENDIX 11. Independent Clinical Trials Service Companies (cont’d) Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing 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. 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 Types of Clients Regulatory Qualifications
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 305 Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing SLC Laboratories www.slclabs.com Victoria Heart Institute Foundation www.vhif.org 204 - 4475 Wayburne Drive, Burnaby, B.C. V5G 4X4 Tel: 604-454-0107 Fax: 604-454-0266 Contact: Project Manager Arthur Yee ayee@slclabs.com #200 - 1900 Richmond Avenue, Victoria, B.C. V8R 4R2 Tel: 250-595-1884 Fax: 250-595-5367 vhif@vhif.org Offers customized analytical and bioanalytical services to the pharmaceutical, natural health product, and functional food industries via high-throughput, automated testing of biological samples. It also provides experience in bioanalytical support for clinical studies in Japan in association with Japanese affiliate Epoch Medical International Inc. Seigiken represents method development and validation as well as sample analysis and regulatory submissions to the Pharmaceutical and Medical Safety Bureau(PMSB), Ministry of Health, Labour and Welfare of Japan. Services include: • Customized method development • Method validation for the parameters of accuracy, precision, calibration fit, recovery and stability •Instrumentation including conventional HPLC and UPLC- MS/MS • High-throughput sample analysis of biological fluids such as blood plasma for active ingredients or oxidative stress biomarkers. Oxygen Radical Absorption Capacity (ORAC) Testing: • Food or health product quality characterization • Manufacturing quality control • Marketing advantage • Active ingredient screening and discovery. Non-profit, charitable organization dedicated to conducting and supporting cardiovascular research on Vancouver Island. Supports a wide range of activities related to cardiovascular research, including: • Cardiovascular drug and device clinical trials, • Continuing medical education, • Training and learning opportunities for graduate trainees in cardiovascular medicine, • Publishing research results in medical journals Conducts Phases I – IV clinical trials. Analytical and bioanalytical laboratory services for clinical studies Located primarily in Vancouver with Canadian and Japanese operations SLC Laboratories is operated by Seigiken Laboratories Canada Inc as a privately held Canadian corporation N/A 11 cardiologists throughout Vancouver Island including VHIF Directors, 5 clinical research nurses, 1 clinical support staff, manager, accountant, 2 other admin N/A Large Pharma, SMEs Hospitals Institutions University Med schools and small operations requiring CT bioanalytical support Types of Clients Regulatory Qualifications Pharma, biotech, CROs, hospitals, research organizations/ institutions SLC services comply with: GLP Trials comply with GCP and ICH
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