醫學/安全事務部由具有豐富的臨床醫學背景和臨床試驗經驗的國內外專業人士組成。 依托多年開展醫療器械臨床試驗及注冊的經驗,基于對國家相關法律法規的熟讀與 理解,能夠進行臨床試驗方案設計、臨床試驗可行性分析及咨詢、臨床試驗報告撰 寫、醫療器械臨床評價報告撰寫、醫學信息檢索、醫學翻譯等內容。作為中立第 三方服務機構,可提供專業的臨床試驗安全管理服務,包括臨床終點事件評審委員 會(CEC)、數據安全監管委員會(DSMB)、AE/SAE事件管理、臨床實踐判定 的管理與協調。 依托“醫心”公眾號開展醫學信息傳播服務,包括醫學專業學術推廣的策劃、創意、實 施;為客戶打造“個體化”設計、制作的專屬醫學信息推廣平臺。
Medical Affairs
The Department of Medical Affairs consists of domestic and foreign professionals with rich clinical medicine background and clinical trial experience.
Based on years of experience in carrying out clinical trials and registration of medical devices, the familiar reading and understanding of relevant national laws and regulations, clinical trial design, clinical trial feasibility analysis and consultation, clinical trial report writing, medical device clinical evaluation report writing, medical information retrieval, medical translation and other content can be conducted.
As a neutral third party service organization, professional clinical trial safety management services, including clinical endpoint event review committee (CEC), data and safety monitoring board (DSMB), AE/SAE event management, and clinical practice judgment management and coordination can be provided.
Relying on the "Yixin" official account, medical information dissemination services, including the planning, creativity and implementation of medical academic promotion can be carried out; moreover, exclusive medical information promotion platform for customers with "individualized" design and production can be designed.
醫學專業服務
醫學信息傳播服務
安全管理
永銘醫學可提供專業的臨床試驗安全管理服務,包括臨床終點事件評審委員會(CEC)、數據安全監管委員會(DSMB)、AE/SAE事件管理、臨床實踐判定的管理與協調。
安全管理團隊成員均具有臨床醫學背景及心血管臨床試驗相關經驗,沿用高標準的專業的SOP,確保臨床終點事件的評審結果客觀準確。
至今共評審了國內外上市前及上市后的多個個心血管相關的臨床研究項目,完成2,000例終點事件CEC的評審。完成了超過5,000例的AE/SAE的事件管理。完成了多個臨床研究項目的數據安全監管委員會(DSMB)的支持工作。