Hsiao-Hui Tsou (Sophie) received her Ph.D. in Mathematical Statistics from the University of Maryland, College Park, in 2005. She did her post-doctoral training in Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taiwan (2005-2008). She was reappointment to be an assistant investigator in Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Taiwan (2008-2013). She is currently an Associate Investigator in Institute of Population Health Sciences, National Health Research Institutes, Taiwan. Dr. Hsiao-Hui Tsou (Sophie) is a clinical biostatistician with more than 12 years involving with all phases of clinical trials in oncology, geriatric, mental health, and substance abuse areas with an established publication record in NHRI. Her research areas include design and analysis in clinical trials, evaluation of bridging study, multi-regional clinical trials, biosimilar clinical trials, and non-inferiority clinical trials. She has presented around 97 presentations, lectures, or short courses in her research area since 2005. Dr. Tsou also devotes herself to education and training courses on clinical trials. She was invited to present over 50 educational lectures or training courses with topics relative to clinical trials.