Abstract
Since the Contract Research Organization, CRO) industry has gradually booming trend in the Asian region, Taiwan has the advantage to development it. It is because the intellectual property rights protection and health care systems that increases the CRO industry companies and the CRO have more opportunities to work together with the sponsors. Therefore, the legal relationship between the sponsors and the CRO becomes more important. However, most papers mostly focused to discuss the legal relationship between the sponsors and experimental subject or the CRO and experimental subject. The legal relationship between the sponsors and the CRO lacks academic discussion, but the practice starts appearing the civil disputes about them. Therefore, this article tries to set the CRO as the discussion center in drug discovery research process, and try to clarify the relationship between civil law and torts responsibility of the CRO. There are six chapters in this thesis. It is summarized in the following paragraphs. The first chapter focuses on the background and status of the CRO industry, described research motivation, research methods and research scope and limitations. The second chapter includes making case analysis about the two cases of the United States and the two domestic cases. In order to realize the civil liability of the CRO, try to discuss contractual liability and tort liability about the CRO. The third chapter will discuss the contract relationship between the sponsors and the CRO. The first section will introduce the rules of the U.S. contracts. The second section will introduce the civil laws about contracts. In the section III, try to make a comparative study of law against US law and domestic civil law about the contractual responsibility of the CRO. The fourth chapter will discuss the tort relationship about the CRO. The first section will introduce the tort law of the U.S. The second section will introduce the civil laws about tort of Taiwan. In the section III, try to make a comparative study of law against US law and domestic civil law about the tort responsibility of the CRO. The fifth chapter will solve the concurrent relationship between the contract and tort. Try to discuss respectively the solution of the U.S. and Taiwan courts. The last chapter will make a conclusion about the civil liability of the CRO.