With the rapid development of the clinical trial industry, the work requirements of each module are becoming more and more specialized. In order to make the pre-start work more efficient, refined, and professional, clinical quick start (SSU) came into being. SSU is primarily responsible for everything from the initial project preparation of clinical trials to the launch of the center. Good SSU work plays a crucial role in the rapid and smooth development of the later projects and the rational overall arrangement. At present, whether it is the sponsor, CRO or SMO company, they have formed their own SSU team.
At 3:00 p.m. on April 11th, we were honored to invite Ms. Du Aihua, Director of the Office of Drug Clinical Trial Institutions of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Mr. Zhou Jian, Director of the Office of Drug Clinical Trials of Wuhan University People's Hospital, Mr. Ren Ke, Vice President of WuXi AppTec and General Manager of WuXi Jinshi, and Ms. Zhao Yafei, Director of Clinical Operations of Wuxi Jinshi and Head of Wuxi Jinshi SSU Team, to be guests in wuxi live broadcast room. From the perspective of authoritative clinical trial institutions, we analyze the advantages and disadvantages of SSU teams in providing leading SSU services, and share and analyze the data of Jinshi cooperation projects. Everyone is welcome to sign up!
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Ms. Du Aihua
Tongji Hospital has been engaged in hospital management for more than 20 years, engaged in clinical trial management for 17 years, has rich experience in scientific research management and clinical trial management, organized and participated in the design and implementation of various clinical trials for many times, and participated in the qualification of drug clinical trial institutions, review inspection and other on-site inspection work organized by China's national and provincial food and drug administrations for many times. He serves as the vice chairman of the Ethics Committee of Pharmaceutical Clinical Trials of Huazhong University of Science and Technology, presides over and participates in the ethical review of various global clinical trial projects, and has his own unique views on ethical issues in clinical trials. He has completed and undertaken several provincial and university-level scientific research projects, published more than 30 management papers, and won the second prize of Hubei Provincial Science and Technology Progress Award. He presided over the declaration of China's national science and technology major special projects "Twelfth Five-Year Major New Drug Creation - Construction of International New Drug Clinical Evaluation Research Technology Platform for Genitourinary Tumors" and "Thirteenth Five-Year Major New Drug Creation - Construction of Comprehensive Service Innovation Platform System for Clinical Evaluation of Diabetes New Drugs with Advanced Technical Characteristics".
Mr. Zhou Jian
Director of the Institutional Office of Wuhan University People's Hospital, Deputy Chief Pharmacist, graduated from Tongji Medical College of Huazhong University of Science and Technology, obtained a master's degree in pharmacology, participated in 1 project of the National Natural Science Foundation of China and the Hubei Provincial Health Department Scientific Research Fund, won 1 third prize of Hubei Province and Wuhan Municipal Science and Technology Progress Award, wrote 4 monographs (deputy editor)," and published more than 10 papers.
As the director of the institutional office for more than 6 years, through continuous practice, the work process of the institutional office has been rectified and optimized, and he has accumulated rich experience in clinical trial management. As the executive director of The Hubei Provincial Society of Clinical Evaluation of Drugs and Medical Devices, as the drug clinical trial data verification inspector of the China Food and Drug Administration and the drug registration inspector of Hubei Province, he has led and participated in the on-site inspection of clinical trial project data and the qualification inspection of institutions and new professions for many times.
Mr. Ren Ke
Ren Ke, currently Vice President of WuXi AppTec and General Manager of WuXi Jinshi, has 20 years of relevant experience in the field of biomedical research and development. He has worked in AstraZeneca, PPD, Scythia and other global pharmaceutical companies, CRO, SMO for many years, engaged in new drug clinical research related operation management, business development and other professional work, in oncology, respiratory, cardiovascular, endocrinology, infection, digestion, neurology, etc. participated in hundreds of innovative drug phase I-III clinical research work, published more than ten articles in related professional journals and held academic positions in multiple academic institutions such as the Alliance of Pharmaceutical Clinical Trial Institutions and DIA, and was rated in 2020" Leading Talents of Huangpu District, Shanghai".
Ren Ke leads the largest clinical research executive team in China, has more than 4500 professional researchers in more than 150 cities in China, has carried out the implementation of more than 2000 clinical research projects with thousands of research centers, and has helped more than 80 new products to successfully pass the FDA verification and listing in the past 7 years, with a pass rate of 100%, including the listing of China's first PD-1 product, China's first Car-T cell therapy product, and the listing of China's first cervical cancer vaccine. The successful implementation of breakthrough projects such as the listing of China's first biosimilar, the first monoclonal antibody biological product approved by Europe and the United States in China, and the first listing of medical device products supported by real-world data in China. He also led the team to establish the industry's leading CTMS clinical operation data center, integrated all projects, personnel, hospital information, finance, business, HR and other sectors of business flow and data flow integration platform, accumulated a large number of clinical research operations to perform first-hand data, and thus won the first prize of the Shanghai Municipal Development and Reform Commission Modern Service Industry Funding Project; independently developed a comprehensive and inexpensive EDC data collection system "Easy Data"; invested in remote monitoring system development company.
Ms. Zhao Yafei
Ms. Zhao Yafei joined WuXi Jinshi on January 5, 2021 as Clinical Operations Director. Responsible for the maintenance and expansion of the relationship between the hospital and the sponsor, SSU operation management, clinical operation optimization and other related work. Ms. Zhao Yafei has rich experience in team management and project operation, has participated in and been responsible for international clinical trials in multiple therapeutic fields such as cardiovascular, blood and respiratory fields, is committed to the construction and management optimization of clinical research teams, the integration of resources and efficiency improvement of multi-project promotion, and has rich front-line experience in center management, quality management and project management in the clinical trial process.
Ms. Zhao Yafei has over 10 years of working experience at Saint-Lange and Remote Medical. Prior to joining WuXi Jinshi, she served as the deputy general manager of the clinical business department of Yaoling Medical and was responsible for clinical operations; she served as the deputy general manager of Shenglange, responsible for the talent echelon construction of SMO operation department personnel, maintaining and developing, and promoting the construction of the company's core culture; providing support for project quality management, seeking solutions to problems and preventive measures; assisting in maintaining good cooperative relations between hospital institutions and researchers; assisting, supporting and guiding the work of the training department and the quality control department. Ms. Zhao holds a bachelor's degree in nursing from Chiang Mai University, Thailand.
About Shanghai WuXi Jinshi Pharmaceutical Technology Co., Ltd
Shanghai WuXi Jinshi Pharmaceutical Technology Co., Ltd. is a wholly-owned subsidiary of Wuxi WuXi AppTec New Drug Development Co., Ltd., an "A+H" listed company, is a medical research service company with SMO clinical research site execution as its main business, with 20 offices throughout China, founded in 2009 and headquartered in Shanghai. Up to now, there is a stable and professional clinical research team of more than 4,000 CRCs in nearly 160 cities in China, with more than 1,800 phase I-IV clinical research project operation experience in oncology, endocrinology, respiration, digestion, neuronology, rheumatism and immunology, ophthalmology, infection, gynecology, nephrology, vaccines and medical devices, and more than 70 varieties of Wuxi Jinshi operation have successfully passed the verification and listing since "722". WuXi Jinshi has in-depth cooperation with more than 1,000 hospitals in China, providing efficient, fast, high-quality and high-verification clinical trial services for more than 300 well-known pharmaceutical companies, CRO, biotechnology and other companies around the world.
The Jinshi SSU team can use its own geographical (Base Hospital), personnel (familiar with institutional and ethical processes), system (internal CTMS system) and other advantages to help the sponsor complete the work from the center screening, feasibility investigation, project approval, ethics, genetic office, contract, pre-start preparation, etc., so as to achieve rapid start-up.
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