Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

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310 BRITISH COLUMBIA APPENDIX 12. Preclinical Studies Service Organizations (cont’d) Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing StarFish Medical www.starfishmedical.com #5-555 Ardersier Rd Victoria, B.C. V8Z 1C8 Tel: 250- 388-3537 Fax: 250-483-1975 President: Scott Phillips sphillips@StarFishmedical. com StarFish Medical are specialists in Medical Device design, development & manufacturing. Product Development Services - StarFish Medical specializes in electro-mechanical devices, diagnostic and imaging equipment. We have expertise in a broad range of areas, including ophthalmology, handheld devices, dental equipment and radiation therapy. Comprehensive turnkey solution for developing medical device products for our clients, from concept through to manufacturing transfer Design control process to ISO 13485 certified Quality Management System. • Turnkey product development solutions • Market needs evaluation and user studies • Regulatory strategy • Quality planning • Product safety testing • Validation and clinical testing • Regulatory submissions USA, Canada, Europe • Manufacturing transfer Manufacturing Services - StarFish is registered as a manufacturer with Health Canada and the FDA, as well as CSA listed. Services include: • Product management • Manufacturing transfer • Process validation • Device master record • Change control • Device assembly • Device calibration and testing • Quality control • Bulk packaging, palleting • Finished good shipping logistics Types of Clients Employees: 35 Serves Canadian and North American companies, institutions and SMEs requiring medical devices development services Regulatory Qualifications StarFish operates under: FDA Class 2 QSR / GMP ISO 13485 – 1996 / CMD CAS ISO 13485 – 1998 Medical Device Directive (MDD) 93/42/EEC/ Medical Devices required for CE marking.
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP 311 APPENDIX 13. ACKNOWLEDGEMENTS This report could not have been created without the participation of the following people: Genome B.C. Gabe Kalmar, Executive Director of Operations Pierre Meulien, Chief Scientific Officer Sally Greenwood, Director, Communications Heather Harris-Harper, BCCRIN Coordinator Margaret Villacin, Administrative Assistant International BioPharma Solutions Ltd. (IBPS) Sue Kingsley, President Helen Kingsley (via IBPS) Tom Seddon (via IBPS) Heather Burt (via IBPS) Rita Jervis (via IBPS) B.C. Ministry of Small Business, Technology and Economic Development Matthew Brown, Senior Portfolio Manager, Investment Capital Branch B.C. Cancer Agency Susan O’Reilly, Vice-President, Cancer Care Delphin Racoma, Cancer Care Sandra Broughton, Regional Administrator, Centre for the Southern Interior Kim Chi, Director Medical Oncology Clinical Trials Unit, Vancouver Centre Andy Coldman, Vice President, Population Oncology Johanna den Duyf, Director, Systemic Therapy (ST) and ST Clinical Trials Unit John French, Director of Clinical Operations. Radiation Therapy Research Program, Vancouver Centre Aly Karsan, Senior Scientist, B.C. Cancer Research Centre Christopher Lee, Medical Director, Edward Miller Clinical Research Unit Fraser Valley Centre Ivo Olivotto, Head, Provincial RT Program Pauline Truong, Vancouver Island Centre Radiation Therapy Research Business Unit Don Wilson, Medical Director, Functional Imaging
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