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探索临床试验路径:构思、设计、实施及结果传播。

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

作者信息

Sampalis John S, Watson Joanne, Boukas Stella, Boukas Marianna, Harvey Natalie, Machado Sanjay, Bordeleau Michel, Rampakakis Emmanouil

机构信息

Scientific Affairs, McGill University, Quebec, Canada; Scientific Affairs, Université de Montreal, Quebec, Canada.

Business Development, JSS Medical Research, Quebec, Canada.

出版信息

Surgery. 2017 Mar;161(3):576-583. doi: 10.1016/j.surg.2016.06.061.

DOI:10.1016/j.surg.2016.06.061
PMID:28190508
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.

摘要

桑帕利斯博士是JSS医学研究公司的创始人、首席执行官兼首席科学官,该公司成立于1997年。他是麦吉尔大学、蒙特利尔大学和拉瓦尔大学的外科学、流行病学与生物统计学终身教授。他被公认为加拿大顶尖的临床流行病学家和创伤研究人员之一,在卫生服务研究、临床试验方面拥有广泛的专业知识,并为众多制药公司、医院以及政府组织和机构提供研究与流行病学咨询服务。沃森夫人拥有达尔豪斯大学药理学硕士学位以及西安大略大学理学学士学位。她的经验涵盖了CRO业务的各个方面以及多个治疗领域。1992年,她与人共同创立了综合研究公司,这是一家提供全方位服务的合同研究组织,并担任该公司的总裁兼首席执行官,直到2014年与JSS医学研究公司合并。沃森夫人目前担任首席商务官,并领导业务发展团队。布卡斯夫人自20世纪90年代JSS医学研究团队成立以来就一直在该团队工作。她拥有麦吉尔大学心理学文学学士学位,并接受过流行病学和生物统计学方面的培训,是临床研究协会(SOCRA)认证的临床研究专业人员(CCRP)。她在医学研究管理方面拥有超过25年的经验。布卡斯夫人目前担任首席运营官,在构建和实施JSS医学研究公司的项目以促进项目管理、站点招募、数据采集和研究跟踪方面发挥了重要作用。布卡斯夫人拥有麦吉尔大学文学学士学位、康考迪亚大学技术通信证书,并接受过SNC拉瓦林制药公司(SLP)和SOCRA的合规培训。她有超过25年的研究经验。1998年加入JSS医学研究公司,她目前担任质量保证(QA)执行董事,自2004年以来负责制定和维护QA计划。QA计划支持在加拿大、拉丁美洲、印度和欧洲开展的临床研究。哈维夫人拥有魁北克大学蒙特利尔分校生物化学理学学士学位以及麦吉尔大学生物学硕士学位。她在制药行业拥有20年的经验,曾在商业和医学部门任职。哈维夫人目前担任JSS医学研究公司临床运营总监,在功能和运营上监督一组项目和数据经理,负责临床研究的开发和实施。马查多博士在印度浦那大学获得医学学位。他在跨国制药、CRO、生物等效性与I期研究以及站点管理组织方面拥有超过20年的经验,涉及多个治疗领域和研究阶段。作为Venn生命科学公司的创始人,马查多博士曾担任首席运营官,直到2011年加入JSS医学研究公司,他目前担任全球运营与整合副总裁。除了监督全球运营外,他还负责通过收购和合并实现JSS医学研究公司的全球扩张和整合。博尔德洛先生拥有圭尔夫大学生物化学理学学士学位以及蒙特利尔高等商学院的工商管理硕士学位。他在制药行业拥有超过20年的经验,包括实验室和IT研究、医疗保健营销支持以及IT团队管理。作为JSS医学研究公司信息技术全球总监,博尔德洛先生领导着一组程序员以及网络、数据库和系统管理员,他们专门负责开发、维护,最重要的是改进关键软件、临床系统、基础设施和业务流程。兰帕卡基斯博士在麦吉尔大学生物化学系获得博士学位,并在麦吉尔大学接受了药物流行病学方面的博士后培训。他拥有超过15年的科研经验,为多个大规模的国内和国际注册及观察性研究的构思、设计、分析和解释做出了贡献。他目前担任JSS医学研究公司科学事务副总裁,监督一组生物统计学家、流行病学家、医生、医学撰写人员和卫生经济学家。

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