Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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302 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 PRA International - Victoria www.prainternational.com PRA International - Victoria 300-655 Tyee Road Victoria B.C. V9A 6X5 Tel : 250-483-4400 Fax: 250-483-4401 Senior Vice President Greg Gurasci Business contact Amelia Orr - PRA Corporate Headquarters 4130 Park Lake Avenue - Suite 400 R aleigh North Carolina 27612 Tel : 919 -786-8200 Large multi-national multi-capability CRO providing International services through all phases of clinical development (Phase I – IV) with facilities in Victoria B.C.. Services world-wide to pharmaceutical and biotech companies in the US, Europe, and Japan. More than 100 complex studies and over 200 bioanalytical studies yearly for studies recruiting healthy volunteers or special patient populations. Study populations include: healthy volunteers, special populations, and populations with specific medical conditions. Has specialities in early Phase I and II clinical trials. Services include: • Feasibility assessments • Protocol design • IMPD and CRF development • Recruitment • Data management • Pharmacy services, including manufacturing • Clinical conduct • Bioanalysis (PK/PD) including biomarkers • Data analysis • Clinical study reports • Medical writing • Regulatory support Phase II and III Studies: PRA assists in Product registration across a range of therapeutic areas, including: • Oncology • CNS • 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. Data management facilities and services located in Victoria B.C. PRA clinical facilities are located in the United States, the Netherlands and Central Europe. A bioanalytical facility is located in Netherlands. 90+ Personnel located at the Victoria office 500 specialists in seven countries International Company with teams worldwide and offices in: • USA • Mexico • S America • UK • Netherlands • Germany • Hungary • Belgium • France • Spain • Poland • Russia • S Africa • Korea • Hong Kong • China • Australia • India Types of Clients Regulatory Qualifications Large Pharma, SMEs Hospitals Institutions University Med schools and small operations requiring CT operations services PRA services comply with: GCP GLP cGMP ICH
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 303 Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing ProHealth Clinical Research Centre www.prohealthcr.ca Syreon Corporation www.syreon.com 600-1285 West Broadway Vancouver, B.C. V6H 3X8 Tel: 604-263-3644 Fax: 604-263-3744 TOLL FREE: 1-866-226-6143. prohealth@prohealthcr.ca 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 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. 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 Located in Vancouver. 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: 8 staff: 3 physicians, 2 research coordinators/ managers, 2 research assistants, 1 admin. Types of Clients Regulatory Qualifications Large and small pharma/biotech N/A Large Pharma, SMEs Hospitals Institutions University Med schools and small operations requiring CT operations services Trials comply with GCP Syreon services comply with: GCP GLP cGMP ICH
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Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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