Core Insights - The company, Taimei Medical Technology, has recently achieved significant milestones, including the global approval of the first load ultrasound echocardiography indication and the first domestic tumor electric field therapy device, bringing the total number of approved projects to 58 across various medical fields [1][2]. Group 1: Project Approvals and Recognition - The IRC team at Taimei Medical Technology has received high recognition from clients for their professionalism and rigorous approach during clinical trials, ensuring accuracy and reliability in evaluation results [2]. - The increasing number of approved projects reflects the company's strong capabilities in navigating regulatory requirements and maintaining high standards in clinical research [1][2]. Group 2: Regulatory Inspection and Compliance - The National Medical Products Administration (NMPA) has raised its inspection standards, focusing on critical aspects that affect the accuracy and independence of image assessments [3][4]. - The eImage system developed by Taimei Medical Technology is highlighted as a crucial tool for meeting these regulatory demands, providing comprehensive tracking and evidence during inspections [3]. Group 3: Inspection Process and Best Practices - The inspection process involves notifying sponsors, executing on-site inspections, and summarizing findings, which requires thorough preparation and documentation [4][5]. - Key areas of focus during inspections include the traceability of case evaluations and adherence to imaging-related protocols [6][7]. Group 4: Team Expertise and Service Strength - The IRC team boasts a strong professional background, with 100% of imaging quality control personnel having medical imaging expertise and all efficacy evaluators holding medical qualifications [8]. - Taimei Medical Technology has established a comprehensive service system, with over 500 project experiences, positioning itself as a reliable partner in the pharmaceutical innovation journey [8].
获批项目达58！太美医疗科技IRC专家分享国家局核查经验