请选择要咨询问题类型
区域伦理
市场准入
为深入贯彻习近平总书记“把人民健康放在优先发展战略地位”的重要指示精神，进一步发挥生物医药产业引领作用，打造具有世界影响力的生物医药科技创新高地，推动生物医药全产业链开放创新，由中国生物医药产业链创新与转化联盟发起，南京市新医药与生命健康产业链工作专班和鼓楼区政府共同推动成立“南京生物医药产业创新转化中心”，充分利用南京生物医药领域创新资源集聚、临床资源丰富的优势，打造“医企融合”发展的产业生态，创建面向长三角地区，辐射全国的生物医药产业临床研究示范基地。
Nanjing Biopharmaceutical Industry Innovation and Transformation Center (hereinafter referred to as the "Innovation and Transformation Center") was initiated by the China Biopharmaceutical Industry Chain Innovation and Transformation Alliance and set up with joint efforts of Nanjing New Biomedical and Health Industry Chain Working Team and Gulou District Government. It was set up with intentions to implement the spirit of General Secretary Xi Jinping's important instructions of "putting people's health at the forefront of the development strategy", and to further play the leading role of the biopharmaceutical industry, as well as to build a biopharmaceutical science and technology innovation highland with world influence promote the opening and innovation of the entire biopharmaceutical industry chain. By making full use of Nanjing's advantages of being the cluster of innovative resources and rich clinical resources in biopharmaceutical sector, the center aims to foster an industrial ecology where "medical-enterprise integration" development are integrated, and to build itself into a clinical research demonstration base for the biopharmaceutical industry oriented to the Yangtze River Delta region and radiating to the whole country.
南京生物医药产业创新转化中心通过“五站一平台”，桥接研发机构、创新型企业、研究型医院与临床研究服务机构，为入驻企业提供覆盖临床试验立项审查、伦理审查、政策研究咨询、对接PI、行业协会交流、项目投融资等临床试验全周期的创新转化服务。中心将发挥鼓楼区高校与大型医院集群的地理优势，为临床试验创新成果转化打通“最后一公里”，为生物医药产业创新研发搭建绿色生态圈。
Through the "Five Stations and One Platform", the Center coordinates R&D institutions, innovative enterprises, research hospitals and clinical research service institutions, and provides settled enterprises with innovation transformation services during the whole cycle of clinical trails such as clinical trial project approval review, ethics review, policy research consultation, PI docking, industry associations exchanges, project investment and financing,etc. The Innovation and Transformation Center will take geographical advantage of being adjacent to famous universities and large hospital clusters to reach the “last mile” of clinical trial innovation transformation with vision to build a green ecology for the R&D of biopharmaceutical industry.
◎Leading PI工作站
致力于提升产业创新链临床研发水平。精确对接研究型医院PI与创新型企业临床合作，为申办方注册研究与研究者发起的临床研究搭建交流协作平台；双向提供从临床调研、立项咨询、方案制定、成果转化等临床研发全周期、全流程、高水平赋能服务。
◎Leading PI Workstation
We are committed to improving the clinical researches and development level of the industrial innovation chain. By accurately coordinating clinical trial cooperation between PI of research hospitals and innovative enterprises, we build a communication and cooperation platform for the registered researches of the applicants and the clinical research initiated by researchers; we provide full-cycle, full-process, and high-level clinical trials empowerment services for both parties such as clinical researches, project consultation, program formulation, and achievement transformation,etc.
◎跨国公司工作站
致力于吸引跨国公司在宁开展国际多中心临床试验与成果转化。为南京都市圈、长三角生物医药研发机构、医疗机构与跨国公司开展药械临床、学术交流、人才培养等各类国际合作，提供政策咨询、临床加速绿色通道等赋能服务。
◎Multinational Enterprises Workstation
In order to attract multinational enterprises to carry out international multi-center clinical trials and achievement transformation Nanjing, the center carry out various international cooperation in areas such as apparatus clinical trials, academic exchanges, and personnel training for biopharmaceutical R&D institutions, medical institutions and multinational enterprises in Nanjing metropolitan area andYangtze River Delta. We also provide empowering services such as policy consultation and clinical acceleration green channels,etc.
◎Innovative Enterprise Workstation
We make endeavors to be the first-class base for innovative enterprises; we are working to match PI for innovative enterprises and filter recommended resources such as CRO, SMO, program design, patient recruitment, application and registration, data statistics, trial insurance,etc; we provide enterprises with value-added services such as expert consultation, clinical acceleration, financing incubation, drug administration application, market access, and talent recruitment,etc.
◎临研服务工作站
致力于打造临床研究一站式服务生态圈。为入驻的临床研究CRO、SMO等领军服务型企业链接南京都市圈临床试验机构与创新型药械企业，提供优质项目对接，CRC、CRA 招募培训、临床加速等赋能服务。
◎Clinical Research Service Workstation
We are devoted to build one-stop service ecology of clinical researches. We explore and coordinate clinical trial institutions and innovative pharmaceutical and apparatus enterprises for leading service-oriented enterprises such as settled clinical research CROs and SMOs in Nanjing metropolitan area. Empowering services such as premium project coordination, CRC, CRA recruitment training, clinical acceleration are provided.
◎行业组织协同工作站
致力于汇聚生物医药产业行业学协会、产业联盟等资源，协同推动“政、产、学、研、医、金”深度融合。为促进行业间学科交叉融合，聚焦产业发展关键共性需求，提供智库咨询服务、技术合作平台、临床资源链接、人才教育培训等赋能服务。
◎Collaborative Workstation for Industry Organizations
We are concentrating on the clustering integration between industry associations and industry alliances in biopharmaceutical industry while promoting the deep synergy among"industries, academic output, researches, hospitals and investment".We promote the interdisciplinary integration and focus on crucial common needs for industrial development by facilitating empowering services such as think tank consulting services, technical cooperation platforms, clinical resource coordination, talent education and training, etc.
◎临床试验数字化平台
致力于搭建开放共享，高效便捷的数字化服务平台。一键受理，多中心伦理协作审查互认，大幅缩短审查周期；探索大数据、云计算、人工智能技术应用于搭建区域PI库、专病库、项目库、患者招募等智能匹配场景。推动数字化系统在临床试验提质增效、降本优化的作用，实现线上线下深度融合。
◎Clinical Trial Digital Platform
We aims to to build an open, shared, efficient and digital service platform with one-click acceptance and multi-centers for ethical collaborative review and mutual recognition, greatly shortening the review cycle; we are exploring the application of big data, cloud computing, and artificial intelligence technologies to build intelligent matching scenarios such as regional PI databases, special disease databases, project databases, patient recruitment, etc. We are keeping to foster the role of digital systems in improving the quality and efficiency while reducing costs in clinical trials to realize the online and offline synergy.