Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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294 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 BRI Biopharmaceutical Research Inc. www.bripharm.com 101 - 8898 Heather Street Vancouver, B.C. V6P 3S8 President David Kwok dkwok@bripharm.com Tel : 604-432-9237 Fax: 604-432-9239 Contract research organization that provides research services to the pharmaceutical, nutraceutical and biotechnology industries in Canada, USA and Asia. Provides specialized and integrated preclinical drug development contract research services for worldwide regulatory submissions. BRI Drug Development Services include: Lead Drug Candidate ADMET Selection: • Pharmacokinetics and Distribution Screening • Biological half-life screening • Serum protein binding using equilibrium dialysis In-vitro red blood cell distribution • Half-life modification Oral Bioavailability Screening: • Oral formulation bioavailability • First-pass hepatic and gut metabolism screening • Metabolism Screening • In-vitro CYP450 metabolic stability screening • LC/MS and LC/MS/MS metabolite profile • Toxicology/Safety Screening • Genotoxicity profiling • Acute MTD study in mice or rat • Chemistry Screening • Aqueous and solvent solubility • Solution pH profile stability Additional services: • Drug Chemistry Patents • In-Vitro / In-Vivo Metabolism • Preclinical Development • CMC Studies • Formulation Development • API and Clinical Product Storage Stability • Clinical Phase I/II Bioanalytical Assays • Clinical Sample Management • Natural Health Product / Dietary Supplement Development • Regulatory Compliance Types of Clients Regulatory Qualifications Large Pharma, SMEs, Hospitals, Institutions, University Med schools, and small operations requiring CT operations services GMP / GLP Establishment License CNSC Nuclear Substance License BRI has established standard ADMET study protocols in collaboration with specialized animal facilities
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 295 Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing Canadian Western Institutional Review Board (WIRB) www.wirb.com Can-Med Clinical Research Inc. www.can-med.ca Suite 400-601 West Broadway Vancouver, B.C. V5Z 4C2 Board Liaison, WIRB Canada Tel : 604 872-5030 Fax 604 872-5032 Client Services Tel : 800-562-4789 clientservices@wirb.com Chair/President of REB: John McNeill PhD Contact: Yi He yhe@wirb.com 330-1641 Hillside Avenue, Victoria, B.C. V8T 5G1 Tel: 250-370-2606 Fax: 250-370-2604 Contact: Cindy Trytten cindy.trytten@can-med.ca Contact: Dr. Peter Pommerville peter.pommerville@can-med. ca Research Ethics Board for Clinical Research Studies in Canada Provides independent IRB services, often to industrysponsored national multi-centre and international clinical trials for Biomedical, Behavioural, Social Sciences studies. Able to provide a broad range of services with the flexibility to meet individual needs while maintaining full regulatory compliance. WIRB provides review services for more than 100 institutions including academic centres, hospitals, networks and in-house biotech research, as well as for individual investigators in all 50 states and internationally. WIRB has worked with all major pharmaceutical and device manufacturers, and CROs; the biotech industry; and is actively developing the internet links for secure, fully-electronic submissions. WIRB Services: • IRB Review • Training • Institutional Biosafety Committee Services (IBCS) • Data and Safety Monitoring Services • Consultations • Exemption Determinations Specializes in clinical trials in urology (including prostate and bladder cancer) on Vancouver Island. The largest urology-focused clinical trial site in Western Canada. Incorporated in 2000, the facility includes 5 private examination rooms used for conducting the informed consent process, discussions with patients and performing study related assessments, a secure investigational product storage room and secure refrigerators, a secure, locked filing room that houses case report forms and source documents for current studies, and private rooms for monitors and auditors. Provides support services to other Investigational Sites, including budget and contract development, SOP templates and on-site training for research coordinators. Committee: Independent (nonaffiliated) For-profit organization based in the US, with representatives located in Vancouver, B.C. Located in Victoria B.C. Dr Peter Pommerville (FRCS(C)) is the Founder and Director of Research. The Board meets every two weeks in its office located in Vancouver B.C.; supported by staff at WIRB headquarters in Olympia Washington. 7 staff: Director of Research, Site Manager, 4 research coordinators, I research assistant Types of Clients Regulatory Qualifications Large Pharma, SMEs, Hospitals, Institutions, University Med schools, and small operations requiring CT REB services Reviews in accordance with: Health Canada Division 5, the Tri Council Policy Statement ICH GCP E6 and US CFR Title 21 Parts 50 and 56 CFR Title 45 Part 46. Large and small pharma/biotech, CROs Trials comply with GCP and applicable federal (Canada and US) regulations
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238 BRITISH COLUMBIA Pediatrics INV
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Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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