Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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APPENDIX 11. INDEPENDENT CLINICAL TRIALS SERVICE COMPANIES Types of Clients Regulatory Qualifications ASKA operates to ICH and GCP Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing SME with Strategic Staff of 8 persons operational part- Vancouver based nering 292 Large Pharma, SMEs, Hospitals, Institutions, University Med Schools, and small operations requiring CT operations services Provides a full range of multi-centre clinical trial management and monitoring services from project conception to marketing approval, from Phase I to IV in all areas of Pharma. No data management or processing. • Clinical Development Planning services include assessment, analysis and preparation of risk-benefit evaluations that assist you in developing business strategies. • Regulatory Services cover the preparation and submission of dossiers to obtain country-specific approvals to conduct clinical trials. • Project Management directing and site selection and ICF and CRF design. Site management and operations. Monitoring/Clinical Research Associates (CRAs): regionally based network of CRAs available for monitoring in any region in Canada. Monitoring services are also accessible through our collaborative partner organizations and our CRO alliance partners in the United States, Australia, Europe and the Asia-Pacific region. Monitoring services encompass all quality control aspects of single or multi-centre clinical research trials. ASKA services also include: • Clinical Research Meeting Planning - facilitation of Clinical Research meetings. • Star Products - custom products and tools for clinical research program activities • Online Training - provider of reference manuals from RAN Institute. • Online GCP training for Sponsors and Monitors • Online GCP training for Investigators and Co-ordinators. • Standard Operating Procedures development • Implementation of FDA, Health Canada & ICH/GCP Guidelines. Corporate Headquarters: #410 - 1385 West 8th Ave Vancouver, B.C. V6H 3V9 Tel : 604-736-3166 Fax: 604-736-1936 info@askaresearch.com Contact: Valerie Willetts valwilletts@askaresearch.com Contact: Les Gee lesgee@askaresearch.com ASKA Research www.askaresearch.com http://askaresearch.trainingcampus.net ICH/GCP and Customized Training - ACRP Credentialed Clinical Research Trainer (CCRT) and a pool of experts Strategic links worldwide: formal operational links through partnering organisations in: • Europe/UK (Harrison Clinical Research) • India • Australia (Clinical Network Services) • US • Japan / Tokyo (ASKLEP) BRITISH COLUMBIA Quality Assurance - compliance with ICH/GCP and applicable regulatory requirements; documented and reported accordingly. Research Professionals Network (RPN) includes experienced monitors and auditors
Types of Clients Regulatory Qualifications • Pharmaceutical Accredited by companies the Diagnostic • Physicians Accreditation • Clinical Program of the Research Profes- B.C. College sionals of Physicians • Canadian, US, and Surgeons; International accredited organizations laboratory with the College of American Pathologists CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing B.C. Biomedical Laborato- 7455 - 130th Street, Surrey, The largest physician-owned (Dr. C.J. Coady Associates) A partnership Staff include: ries Ltd. B.C. V3W 1H8 and operated laboratory in B.C. Its medical diagnostic comprised of • Members of www.bcbio.com Contact for clinical trials: services are an integral part of the B.C. health care system, over 40 leading Clinical Research Tel: 604-507-5091 or 604- with more than 1.9 million patients visiting one of its 45 practitioners in all Professionals of 507-5170 Patient Service Centres throughout the Lower Mainland. B.C. disciplines of labo- B.C (CRPBC) Fax: 604-507-5212 Biomed also provides collection, management, and testing ratory medicine • TDG/IATA BusinessAccounts@bcbio- services for the following: trained staff medical.com • Clinical Trials for local and • Scientific Research international • Special Studies transport of • Pre-employment Testing specimens • Insurance Kits • Toxicology • Occupational Testing • Wellness Testing B.C. COT conducts its clinical research projects in accordance with ICH/GCP. Large and small pharma/biotech Consists of 7 oncologists and a clinical trials coordinator Members: Dr. Paul Klimo, Dr. John Yun, Dr. Michael Noble, Dr. David Stuart, Dr. Sasha Smiljanic, Dr. Simon Yu A research study will be set up at a one of the office sites and satellite sites will be added if multiple investigators are interested. Independent research company formed by oncologists that work outside the BCCA in community oncology sites. B.C. COT conducts phase II-IV clinical research studies out of their private offices using a central ethics board, in particular IRB Services. These private offices are located in Richmond, Burnaby and North Vancouver B.C. To date B.C. COT has conducted 9 successful clinical trials using this infrastructure, and continues to look for new and interesting protocols in the fields of hematology and oncology. B.C. COT is also extensively involved in continuing medical education in the community. Contact: Ryan Tkachuk, Research Coordinator. B.C. Community Oncology Trialists 705-4980 Kingsway, Burnaby B.C., V5H 4K7 Tel: 604-836-5340 tkservices@shaw.ca Director: Wendy Lam B.C. Community Oncology Trialists (BCCOT) No URL 293
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1 33 0 34 0 M A G N E T I C V A R 9
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ii BRITISH COLUMBIA
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2 EXECUTIVE SUMMARY BRITISH COLUMBI
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4 INTRODUCTION BRITISH COLUMBIA Wit
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6 Health Authority (URL) Key Facili
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8 FIGURE 2. Clinical Trials Units,
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10 Facility (URL if available) Pedi
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12 Facility (URL if available) Mood
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14 Facility (URL if available) Down
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16 Facility (URL if available) Clin
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18 Facility (URL if available) Gast
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20 TABLE 3. Clinical Trials Support
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22 Much clinical research - particu
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24 FIGURE 3. Source of Funds for Cl
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26 BRITISH COLUMBIA FIGURE 7. Thera
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28 BRITISH COLUMBIA Clinical Invest
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Disease Area Population Information
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32 CV/Cardiology CNS Pulmonary Canc
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34 TABLE 9. Health Economics and He
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36 TABLE 10. Epidemiology and Surve
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38 TABLE 12. Provincial Networks Th
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40 Network B.C. Investigator’s Ro
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42 Network B.C. Investigator’s Ro
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44 TABLE 14. Independent Clinical T
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46 COMPARATIVE POSITIONING OF B.C.
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48 ACKNOWLEDGEMENTS BRITISH COLUMBI
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50 APPENDIX 1-2 TABLE OF CONTENTS B
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52 PROVINCIAL HEALTH SERVICES AUTHO
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54 BRITISH COLUMBIA Edward Miller C
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56 BRITISH COLUMBIA Radiation Thera
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58 The Unit has 15 Principal Invest
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60 BRITISH COLUMBIA Neonatal Resear
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62 The B.C. Children’s Hospital p
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64 BRITISH COLUMBIA The clinical tr
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66 FRASER HEALTH AUTHORITY BRITISH
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68 BRITISH COLUMBIA tional therapis
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70 PROVIDENCE HEALTH CARE SOCIETY 4
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72 BRITISH COLUMBIA Quality control
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74 Clinical trials investigators in
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76 The facility has 13 investigator
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78 Staffing of the Centre is as fol
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80 Investigators: • Ayas, Najib
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82 BRITISH COLUMBIA Quality control
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84 The Research Group consists of t
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86 BRITISH COLUMBIA Multiple Sclero
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88 BRITISH COLUMBIA Gastroenterolog
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Since the Centre is located in St.
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TABLE A1. Providence Health Care So
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94 BRITISH COLUMBIA FIGURE A9. Cent
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96 BRITISH COLUMBIA The Unit suppor
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TABLE A2. CFRI Program-affiliated R
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100 BRITISH COLUMBIA Quality contro
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102 BRITISH COLUMBIA • Knowledge
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104 Its staffing is as follows: Stu
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106 APPENDIX 3. QUALITY CONTROL/ QU
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APPENDIX 5. CLINICAL TRIALS TRAININ
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APPENDIX 5. Clinical Trials Trainin
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112 APPENDIX 6 TABLE OF CONTENTS BR
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6.1 Clinical Trials Researchers Lis
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Pediatrics INSTITUTION EMAIL URL DI
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Pediatrics (cont’d) INSTITUTION E
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Page 252 and 253: 248 APPENDICES 7-13 TABLE OF CONTEN
Page 254 and 255: 250 TABLE A3. Patient and Addiction
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Page 262 and 263: 258 APPENDIX 9. Healthcare Research
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Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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