近日，太美医疗科技IRC团队接连收获喜讯——助力瑞加诺生在全球范围内首次获批负荷超声心动图适 应症、助力首款国产肿瘤电场治疗仪获批。至此，由太美医疗科技提供IRC服务且获批的项目数量达到 58个，涵盖实体瘤、血液瘤、中枢神经、消化、心血管、核药等多个领域的药品及医疗器械产品，稳居 行业前列。 获批项目数量稳步攀升的同时，IRC团队也得到了来自客户的高度认可。 "整个试验期间，太美医疗科技IRC团队展现出极高的专业素养和严谨负责的态度，无论是在影像数据 的传输、质控，还是独立阅片、终点判定，均严格遵循试验方案与标准操作流程，确保了评估结果的准 确性、一致性和高可靠性；尤其是在国家局现场核查阶段，给予了无懈可击的支持与配合，面对核查专 家的细致审视，准备充分、应对专业、沟通顺畅，其卓越表现赢得核查专家及我方项目组高度评价。" ——某申办方临床运营负责人 本文将分享太美医疗科技IRC团队在核查全程中的数点经验，供行业同仁交流分享。 国家局核查水平提升迅速，如何应对？ "从最近的核查经验来看，国家局的核查要求在不断提升，提出的问题往往能精准命中要害，"太美医疗 科技IRC业务专家透露，"尤其是涉及到影响阅片准确性与独 ...

Group 1 - Kangaroo Cloud has been selected as one of the Top 10 Best Data Intelligence Software Vendors in China's Xinchuang Industry for 2025, highlighting its significant role in digital transformation and high-quality industrial development [2] - Kangaroo Cloud has achieved full-chain Xinchuang adaptation, covering various components such as databases, operating systems, CPUs, servers, cloud platforms, big data foundations, data integration tools, and data processing tools [2] - The company emphasizes independent research and development, technological innovation, and aims to provide integrated Xinchuang solutions driven by data intelligence and AI technologies [2] Group 2 - All-Knowing Technology's data security monitoring solution, developed in collaboration with China Life Property Insurance, has been recognized as an excellent practice case in the 2025 "Pan'an" initiative [3] - The company's products in the data security field have been included in the "Digital Security Protection Technology Capability Panorama," showcasing its expertise in data security and compliance [3] Group 3 - Taimei Medical Technology has achieved a record of 47 approved projects for its IRC services, with 72 projects submitted for NDA applications and 65 projects passing verification [5] - The IRC team has rapidly grown since the launch of the eImage system in 2017, enhancing its professional capabilities to support innovative drug development in China [5] Group 4 - Hepalink Pharmaceutical has been recognized in the "2025 Sustainable Innovation Case List" for its record-setting licensing transaction [14] - This recognition underscores Hepalink's innovative contributions to the biotechnology sector [14] Group 5 - Xuanwu Cloud has been awarded the "ESG Corporate Governance Excellence Enterprise" award for its outstanding performance in corporate governance [17] - The award emphasizes the company's commitment to compliance, risk management, and a clear governance structure, reflecting its potential for sustainable development [17] Group 6 - Moan Technology has been selected as a technical support unit for network and data security emergencies in Anhui Province, affirming its technical capabilities and emergency response system [19] - The company has also been recognized in the "Digital Security Protection Technology Capability Panorama," showcasing its strengths across multiple security domains [22]