臨床試驗eClinical
02-25175175
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台北市中山區松江路237號
美商賽美斯醫學科技有限公司(以下簡稱CIMS Global)擁有超過16年的行業經驗,致力於改革臨床試驗。CIMS Global希望透過自主研發的eClinical suite和在動態試驗設計和動態數據監控的經驗上,持續對臨床試驗產業帶來前所未有的變革。透過CIMS Global的系統能夠協助製藥和生物技術公司加速藥物開發,節省大量臨床試驗成本,並更快地將治療療法帶給患者。 CIMS Global總部位於美國新澤西州並且在中國成都亦設有分公司。與此同時CIMS Global在美國和中國與上百家大型的醫藥或是醫療器材公司有著穩定且長期的合作關係。 With over 16 years of industry experience, we have pioneered the reshaping of clinical trials. CIMS Global is committed to revolutionizing the industry through our existing eClinical suite, and expertise in Dynamic Trial Design and Dynamic Data Monitoring. With our proprietary closed system, we empower pharmaceutical and biotech companies to expedite the drug development process, saving millions of dollars on clinical trials, and bringing life-saving therapies to patients faster. Our primary focus lies in the development of innovative eClinical and eHealth solutions, as well as leveraging data sciences for the benefit of the drug and healthcare industries. By combining cutting-edge technology with our deep understanding of the clinical trial landscape, we drive significant advancements and improve patient outcomes. The CIMS Dynamic Trial Design, Dynamic Data Monitoring engine and complete eClinical / IWRS platform is a result of over 20 years of innovation led by CIMS founder, Tai Xie, Ph.D. Driven by a passion to optimize the clinical trial process, Dr. Xie sees the convergence of EDC and IWRS, statistical modeling and machine learning that can reshape the future of clinical trials. You can find more information about us on LinkedIn. https://www.linkedin.com/company/cims-global ▌Record of Participation in Industry Events ├── 2023 │ ├── ●BBSW 2023, the sponsor and speakers of session │ └── https://reurl.cc/r6oqYk ├── 2024 │ ├── ●Joint Statistical Meetings (JSM) for DMC-HUB+DDM™ │ └── https://reurl.cc/74aYnb │ ├── ●BBSW 2024, October 24-25 │ └── https://reurl.cc/36zyMM │ ├── ●PharmaSUG 2024 paper presentations - ST-381 │ └── https://reurl.cc/qnEa2R ├── 2025 │ ├── ●SCOPE Summit 2025 in Orlando │ └── https://reurl.cc/KdGEly │ ├── ●PHUSE US Connect 2025 │ └── https://reurl.cc/26n784
【A Passion for Improving the Clinical Trial Process】 AI + Statistical Modeling + eClinical is creating a new paradigm ▌Dynamic Trial Design 69.3% of Phase II studies don’t make it to Phase III. 41.9% of Phase III studies don’t make it to NDA. The majority of drugs studied under traditional design with one final analysis ultimately fail. Because of these high failure rates, there is an urgent need to dramatically improve study design and implement today’s advanced technology during the clinical trials process. Dynamic Trial Design eliminates the time constraints caused by Group Sequential Design (GSD) and Adaptive Group Sequential Design (AGSD) by leveraging Machine Learning and AI to turn Adaptive Group Sequential Design into a dynamic, real-time study evaluation. ▌Dynamic Data Monitoring The CIMS Dynamic Data Monitoring engine utilizes machine learning and artificial intelligence (AI) technology in an integrated, closed system with EDC and IWRS. With the CIMS DDM platform, you can dynamically monitor and optimize your clinical trials — overcoming the drawbacks of classical adaptive group sequential designs to monitor trials without an Independent Statistical Group (ISG) and/or Independent Data Monitoring Committee (IDMC). As new data is accumulated, the system will automatically compute the score function for chosen endpoints, confidence intervals and conditional power; update stopping boundaries; and perform simulations to predict the trend of a clinical trial. ▌eClinical solutions The CIMSTM eClinical Suite is a cloud-based, fully-validated 21CFR11 compliant intelligent platform that enables users to intuitively manage the complexities of clinical trials by sharing consistent trial data across the entire trial process. This allows the sponsor to seamlessly manage trial processes, effectively deploy critical resources, proactively address performance issues and streamline operational workflows. Access comprehensive EDC modules connected to smart mobile apps to streamline the clinical trial process from study setup to regulatory submission.