Navigating the clinical trial pathway: Conception, design, execution, and results dissemination

作者:Sampalis John S*; Watson Joanne; Boukas Stella; Boilkas Marianna; Harvey Natalie; Machado Sanjay; Bordeleau Michel; Rampakakis Emnianouil
来源:Surgery, 2017, 161(3): 576-583.
DOI:10.1016/j.surg.2016.06.061

摘要

Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology &' Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies. Mrs. Watson holds a M.Sc. in Pharmacology from Dalhousie University, and a B.Sc. from the University of Western Ontario. Her experience extends to all facets of the CRO business, and multiple therapeutic areas. She co-founded, in 1992, Integrated Research Inc, a full-service contract research organization, and served as its President and Chief Executive Officer, until merging with JSS Medical Research Inc in 2014. Mrs. Watson currently holds the position of Chief Business Officer, and is head of the business development team. Mrs. Boukas has been working with the JSS Medical Research team since its inception in the 1990s. She holds a B.A. in Psychology from McGill University with training in Epidemiology and Biostatistics, and is certified by the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP). She has over 25 years' of experience in medical research management. Currently Chief Operations Officer, Mrs. Boukas has been essential in structuring and implementing programs at JSS Medical Research Inc to facilitate project management, site recruitment, data capture and study tracking. Mrs. Boukas holds a B.A. from McGill University, a Certificate in Technical Communications from Concordia University and has received compliance training from SNC Lavalin Pharma (SLP) and SOCRA. She has over twenty-five years' experience in research. Joining JSS Medical Research Inc in 1998, she currently holds the position of Executive Director of Quality Assurance (QA) where she developed and maintains the QA Program since 2004. The QA Program supports clinical studies conducted in Canada, Latin America, India and Europe. Mrs. Harvey holds a B.Sc. in Biochemistry from the University du Quebec a Montreal and a M.Sc. in Biology from McGill University. With 20 years' experience in the pharmaceutical industry, she has held positions in both Commercial and Medical departments. Mrs. Harvey currently holds the position of Director, Clinical Operations at JSS Medical Research Inc, functionally and operationally overseeing a team of project and data managers in the development and implementation of clinical studies. Dr Machado obtained his medical degree from the University of Pune, India. He has over 20 years' experience in multinational pharmaceutical, CRO, Bioequivalence & Phase I and Site Management Organizations, working in several therapeutic areas and phase of studies. As a founder of Venn Life Sciences, Dr Machado served as Chief Operating Officer, until joining JSS Medical Research Inc in 2011, where he is currently Vice-President, Global Operations & Integration. In addition to overseeing global operations, he is responsible for global expansion and integration of JSS Medical Research Inc through acquisitions and mergers.

  • 出版日期2017-3
  • 单位McGill

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