All pharmaceutical products must be approved by the Ministry of Health, Labour and Welfare before they can be marketed in Japan, and the efficacy and safety of the drug candidate must be verified by administering the drug to patients in pre-approval clinical trials that are supported and carried out by companies known as Contract Research Organizations (CRO). The role of the CRO has continued to expand due to the growing trend by pharmaceutical companies to outsource their clinical trials in their effort to pursue research that is flexible and efficient within the limitations  of their development staff. As a specialized CRO, we focus on the most vital stages of the clinical trial, namely the phase II and phase III studies, to include major activities such as monitoring, quality control, and Consulting Activities. Our goal is to become a true partner of biotech and pharmaceutical companies by providing high-quality clinical trial services.