title: Navigating the clinical trial pathway: Conception, design, execution, and results dissemination.
abstract: 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 Université du Québec à Montréal 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. Mr. Bordeleau holds a B.Sc. in Biochemistry from the University of Guelph and an MBA from HEC Montreal. He has over 20 years' experience in the pharmaceutical industry, including laboratory and IT research, healthcare marketing support, and IT team management. As Global Director of information Technology at JSS Medical Research Inc, Mr. Bordeleau leads a team of programmers as well as network, database and system administrators who specialize in developing, maintaining, and most importantly, improving, key software, clinical systems, infrastructure, and business processes. Dr Rampakakis received his Ph.D. from the Department of Biochemistry from McGill University, and obtained post-doctoral training, also at McGill, in Pharmacoepidemiology. With over 15 years' experience in scientific research, he has contributed in the conception, design, analysis and interpretation of several large scale, national and international, registration and observational studies. He currently holds the position of Vice President of Scientific Affairs at JSS Medical Research Inc, overseeing a team of biostatisticians, epidemiologists, physicians, medical writers, and health economists.
authors.affiliation: Scientific Affairs, McGill University, Quebec, Canada; Scientific Affairs, Université de Montreal, Quebec, Canada. Electronic address: submissions@jssresearch.com.
authors.forename: John S
authors.initials: JS
authors.lastname: Sampalis
authors.affiliation: Business Development, JSS Medical Research, Quebec, Canada.
authors.forename: Joanne
authors.initials: J
authors.lastname: Watson
authors.affiliation: Clinical Operations, JSS Medical Research, Quebec, Canada.
authors.forename: Stella
authors.initials: S
authors.lastname: Boukas
authors.affiliation: Quality Assurance, JSS Medical Research, Quebec, Canada.
authors.forename: Marianna
authors.initials: M
authors.lastname: Boukas
authors.affiliation: Clinical Operations, JSS Medical Research, Quebec, Canada.
authors.forename: Natalie
authors.initials: N
authors.lastname: Harvey
authors.affiliation: Clinical Operations, JSS Medical Research, Quebec, Canada.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Machado
authors.affiliation: Information Technology, JSS Medical Research, Quebec, Canada.
authors.forename: Michel
authors.initials: M
authors.lastname: Bordeleau
authors.affiliation: Scientific Affairs, JSS Medical Research, Quebec, Canada.
authors.forename: Emmanouil
authors.initials: E
authors.lastname: Rampakakis
mesh_terms: D002986:Clinical Trials as Topic / Q000458:organization & administration*; D018795:Device Approval; D017277:Drug Approval; D006801:Humans; D012107:Research Design; D014481:United States