Regulation, Culture, and Communication: The Global Environment of Clinical Device Trials

The intent of my research and thesis was to gain a greater understanding of the role of regulation, culture, and communication within the global clinical trial environment. I wanted to explore if these topics are affecting the market development of international clinical device trials and if so, to what extent. I will begin with a Literature Review, discussing the history of regulatory development in the United States and around the world. I will also present information on current aspects of culture and communication within the medical device industry as they relate to the clinical trial environment and globalization of clinical research. After the Literature Review, I will include a section that outlines that activities with which I was involved during my internship at MedTrials Incorporated of Dallas, TX. I will chronologically present those activities and experiences as recorded in my journal. I will complete my thesis by discussing the results of my research and internship, exploring the global regulatory environment, culture and communication within the context of an international clinical trial to which I was assigned. My internship experience allowed me to become familiar with the concepts and principles realized through my research and understand the specific affect and application of regulation, communication, and culture in the industry today.