CRC服務
臨床試驗現場管理組織（Site Management Organization, SMO）是協助臨床試驗機構進行現場管理和具體操作的專業服務機構，SMO主要通過派遣臨床研究協調員（Clinical Research Coordinator CRC）協助研究者和研究機構承擔臨床試驗中非醫學判斷類的事務性工作，提高臨床試驗質量和進度，確保臨床試驗過程的符合GCP和研究方案的規定。
瑞旭集團為醫療器械臨床研究提供專業的SMO服務，包括前期臨床試驗準備、現場執行、項目全流程管理等服務，公司委任的項目經理和CRC組成的項目團隊，與申辦方、臨床試驗機構、研究者、CRO進行溝通，確保臨床試驗進程和規范化。
豐富的項目經驗
瑞旭集團CRC服務項目包括醫療器械注冊申報臨床試驗、上市后臨床評價和研究者發起的各類臨床研究。如手術機器人、人工晶狀體、角膜接觸鏡、注射美容填充的交聯透明質酸鈉凝膠、一次性電子內窺鏡、可吸收美容提拉線等項目。
我們的服務
臨床試驗階段 | 服務內容 |
1. 臨床試驗準備階段 | - 篩選和推薦研究中心和研究者
- 協助研究中心可行性調研
- 協助倫理遞交并跟進倫理審查
- 協助臨床研究協議洽談與簽署
- 協調并參與研究中心啟動會
- 研究人員協調與培訓
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2. 臨床試驗啟動實施階段 | - 協助受試者召募和管理
- 協助安全信息的報告和追蹤
- 試驗物質管理
- 病例報告表的錄入及數據疑問解答
- 原始資料的收集及整理
- 倫理溝通及文件遞交
- 配合監查、稽查和核查
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3. 臨床試驗結題階段 | - 協助清理數據
- 試驗物質回收
- 票據的收集和管理
- 項目文件整理歸檔
- 協助質控和稽查
- 協助數據核查
|
掃描下方的二維碼訂閱“CIRS醫械合規動態”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
① 凡本網注明"稿件來源：“杭州瑞旭科技集團有限公司"的所有文字、圖片和音視頻稿件，版權均屬杭州瑞旭科技集團有限公司所有，任何媒體、網站或個人未經本網協議授權不得轉載、鏈接、轉貼或以其他方式復制發表。已經本網協議授權的媒體、網站，在下載使用時必須注明"稿件來源：杭州瑞旭科技集團有限公司"，違者本網將依法追究責任。
② 本網未注明"稿件來源：杭州瑞旭科技集團有限公司 "的文/圖等稿件均為轉載稿，本網轉載出于傳遞更多信息之目的，并不意味著贊同其觀點或證實其內容的真實性。如其他媒體、網站或個人從本網下載使用，必須保留本網注明的"稿件來源"，并自負版權等法律責任。如擅自篡改為"稿件來源：杭州瑞旭科技集團有限公司"，本網將依法追究責任。如對稿件內容有疑議，請及時與我們聯系。
③ 如本網轉載稿涉及版權等問題，請作者在兩周內速來電或來函與杭州瑞旭科技集團有限公司聯系。
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