Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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APPENDIX 11. Independent Clinical Trials Service Companies (cont’d) Types of Clients Regulatory Qualifications PRA services comply with: 302 GCP GLP cGMP ICH Large Pharma, SMEs Hospitals Institutions University Med schools and small operations requiring CT operations services BRITISH COLUMBIA Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing PRA International - Victoria PRA International - Victoria Large multi-national multi-capability CRO providing Inter- Data manage- 90+ Personnel www.prainternational.com 300-655 Tyee Road national services through all phases of clinical development ment facilities and located at the Victoria B.C. V9A 6X5 (Phase I – IV) with facilities in Victoria B.C.. services located in Victoria office Tel : 250-483-4400 Services world-wide to pharmaceutical and biotech compa- Victoria B.C. 500 specialists in Fax: 250-483-4401 nies in the US, Europe, and Japan. More than 100 complex seven countries Senior Vice President studies and over 200 bioanalytical studies yearly for studies PRA clinical facili- International Greg Gurasci recruiting healthy volunteers or special patient populations. ties are located in Company with Business contact Study populations include: healthy volunteers, special popu- the United States, teams worldwide Amelia Orr lations, and populations with specific medical conditions. the Netherlands and offices in: - Has specialities in early Phase I and II clinical trials. and Central Europe. • USA PRA Services include: A bioanalytical • Mexico Corporate • Feasibility assessments facility is located in • S America Headquarters • Protocol design Netherlands. • UK 4130 Park Lake • IMPD and CRF development • Netherlands Avenue - Suite 400 R • Recruitment • Germany aleigh • Data management • Hungary North Carolina • Pharmacy services, including manufacturing • Belgium 27612 • Clinical conduct • France Tel : 919 • Bioanalysis (PK/PD) including biomarkers • Spain -786-8200 • Data analysis • Poland • Clinical study reports • Russia • Medical writing • S Africa • Regulatory support • Korea Phase II and III Studies: PRA assists in Product registration • Hong Kong across a range of therapeutic areas, including: • China • Oncology • Australia • CNS • India • Respiratory/allergy • Gastroenterology • Immunology Phase II / III Services include: • Regulatory Affairs. • Project management - Project Start-up • Clinical Site Monitoring Services • Event reporting procedures • Support structures for clinical teams.
Types of Clients Regulatory Qualifications Trials comply with GCP Large and small pharma/biotech Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing ProHealth Clinical Research Located in Van- 8 staff: 3 physi- Centre couver.cians, 2 research www.prohealthcr.ca coordinators/ managers, 2 research assistants, 1 admin. Specializes in clinical research in the areas of men’s health, postmenopausal women’s health, metabolic bone diseases (osteoporosis) and endocrine disease (including diabetes). Conducts Phases I – IV clinical studies. The Centre’s director, Dr. David Kendler, is Director of the Osteoporosis Program at Providence Health Care. 600-1285 West Broadway Vancouver, B.C. V6H 3X8 Tel: 604-263-3644 Fax: 604-263-3744 TOLL FREE: 1-866-226-6143. CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP prohealth@prohealthcr.ca Syreon services comply with: 260 - 1401 West 8th Avenue Vancouver, B.C. V6H 1C9 Director, Business Development - Brendan Keown brendan.keown@syreon.com Head of Project Management: Rohinish.Gunadasa@syreon. com Tel: 604-676-5900 Fax : 604-676-5911 info@syreon.com Syreon Corporation www.syreon.com GCP GLP cGMP ICH N/A Large Pharma, SMEs Hospitals Institutions University Med schools and small operations requiring CT operations services 303 Major Clinical trial management, support and operations capability based in Vancouver. Multinational CRO with divisions in Canada - Vancouver and Montreal and Budapest, Hungary. Multi-centre and multinational programs integrated over 1,000 academic and community sites in more than 40 countries throughout the Americas, Europe, Africa, the Middle East, Australia, and Asia. Syreon Committees: Clinical trial research corporation specializing in support services (e.g., management, data processing and management) to biopharmaceutical companies worldwide, providing high quality information and data services through the use of electronic systems for international health research. Provides expertise in molecular medicine, biostatistics, clinical therapeutics, economics, health outcomes measurement, and economics to conduct national and international Phase I to IV clinical and pharmacovigilance studies. Extensive experience in all areas of clinical research, extending from developmental therapeutics to formal clinical trials and longitudinal disease-based registry studies in a broad range of therapeutic areas from infectious diseases to complex multisystem disorders. Syreon Services Include: • Study management: Study and project management services to ensure that trials are conducted in accordance with the most stringent scientific and operational objectives. Options for Senior Tier Study Management models, customized to the requirements of each Sponsor and study, are shown in the following sections. • Site management: ClinStream technology facilitates on-line site training and certification, study education and GCP training to speed IRB submission and approval, and to facilitate patient selection, enrolment and randomization. • Monitoring Services: through a network of site monitoring
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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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248 APPENDICES 7-13 TABLE OF CONTEN
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250 TABLE A3. Patient and Addiction
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Page 258 and 259: APPENDIX 8. PROVINCIAL AND NATIONAL
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