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The development of Site Management Organization (abbreviated as SMO) has gone through several stages. With the increasing demand for SMO companies from multinational pharmaceutical companies and local pharmaceutical manufacturers, the participation of SMO companies has led to an improvement in the quality of clinical trials. SMO companies have entered a stage of large-scale development, and their service scope has gradually expanded to clinical trial management. Driven by industry development and big data platforms, SMO companies have optimized management processes, improved management efficiency, and achieved professionalization, specialization, and intelligentization of clinical trial managers. Due to his passion for conducting clinical trials, the CEO started in 2015 and established JY Support Ltd. in May 2024, providing more comprehensive training for clinical trial personnel through an experienced and well-trained professional team.
The role of SMO services in clinical trials is becoming increasingly important. All trials are considered a scientific, ethical, and moral responsibility, and scientific research prioritizes authenticity, transparency, and safety. Clinical trial investigators often perform routine clinical treatments and clinical trials simultaneously, but an effective balance needs to be struck between the two. Therefore, SMO companies play a crucial role by providing on-site management services through the deployment of professional Clinical Research Coordinators (CRCs) or Study Coordinators (SCs). They assist investigators in completing tasks such as data collection, Electronic Data Capture entry, document and specimen collection, and transportation in clinical trials. Everything becomes more efficient after we join.
Through our professional consulting team, we execute high-quality clinical trials and have extensive inspection experience. We are committed to developing domestic and international trials and establishing personnel training plans. Our vision is to become a professional, excellent, and efficient clinical trial service consulting company, Site Management Organization (SMO), and provide comprehensive support and services for your clinical research.
Our team has multiple inspection experiences with the U.S. Food and Drug Administration (U.S. FDA) and the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. We also have extensive practical experience in executing clinical trials in various fields, including oncology, hematology, urologic oncology, general internal medicine, surgery, obstetrics, and pediatrics. In medical device trials, we have collaborated with several clinical trial institutions, including National Taiwan University Hospital, Taipei Medical University Hospital, and Taipei Veterans General Hospital.
Education
- Master's Degree in Clinical Research (Clinical Trials Group) from Taipei Medical University
- Bachelor's Degree in Health Care Management from Taipei University of Nursing and Health Sciences
Expertise
- Skilled in planning events for over 100 people
- Participated in various hospital accreditations and coordinated visits from external organizations
- Planned subject recruitment strategies and directions based on study characteristics, identified available databases to accelerate subject recruitment and shorten enrollment time
- Assisted in the execution and completion of multiple BE/BA studies, medical device trials, domestic vaccine trials, and international clinical trials from Phase I to Phase IV