Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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292 BRITISH COLUMBIA APPENDIX 11. INDEPENDENT CLINICAL TRIALS SERVICE COMPANIES Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing ASKA Research www.askaresearch.com http://askaresearch.trainingcampus.net 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 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. SME with Strategic operational partnering Strategic links worldwide: formal operational links through partnering organisations in: • Europe/UK (Harrison Clinical Research) • India • Australia (Clinical Network Services) • US • Japan / Tokyo (ASKLEP) Staff of 8 persons Vancouver based Types of Clients Regulatory Qualifications Large Pharma, SMEs, Hospitals, Institutions, University Med Schools, and small operations requiring CT operations services ASKA operates to ICH and GCP ICH/GCP and Customized Training - ACRP Credentialed Clinical Research Trainer (CCRT) and a pool of experts Quality Assurance - compliance with ICH/GCP and applicable regulatory requirements; documented and reported accordingly. Research Professionals Network (RPN) includes experienced monitors and auditors
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 293 Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing B.C. Biomedical Laboratories Ltd. www.bcbio.com B.C. Community Oncology Trialists (BCCOT) No URL 7455 - 130th Street, Surrey, B.C. V3W 1H8 Contact for clinical trials: Tel: 604-507-5091 or 604- 507-5170 Fax: 604-507-5212 BusinessAccounts@bcbiomedical.com 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 The largest physician-owned (Dr. C.J. Coady Associates) and operated laboratory in B.C. Its medical diagnostic services are an integral part of the B.C. health care system, with more than 1.9 million patients visiting one of its 45 Patient Service Centres throughout the Lower Mainland. B.C. Biomed also provides collection, management, and testing services for the following: • Clinical Trials • Scientific Research • Special Studies • Pre-employment Testing • Insurance Kits • Toxicology • Occupational Testing • Wellness Testing 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. A partnership comprised of over 40 leading practitioners in all disciplines of laboratory medicine 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. Staff include: • Members of Clinical Research Professionals of B.C (CRPBC) • TDG/IATA trained staff for local and international transport of specimens 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 Types of Clients Regulatory Qualifications • Pharmaceutical companies • Physicians • Clinical Research Professionals • Canadian, US, International organizations Accredited by the Diagnostic Accreditation Program of the B.C. College of Physicians and Surgeons; accredited laboratory with the College of American Pathologists Large and small pharma/biotech B.C. COT conducts its clinical research projects in accordance with ICH/GCP.
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