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一、临床试验运营管理、项目管理Clinical Operation and Project Management
      项目运营管理 Project Operation Management
      监查管理 Monitoring
      数据管理 Data Management
      统计分析 Statistical Analysis
      安全管理 Safety Management
      团队人员管理 Manpower Management
      质量控制 Quality Control

二、临床监查Clinical Monitoring/Site Management
      监查团队Monitoring Team
      包括项目经理、高级临床监查员、临床监查员和区域临床监查员组成,他们当中大多数具备3年以上医疗器械临床研究      监查经验及培训经历。
      Including project managers, sCRAs, CRAs, most of them has over 3 years clinical trail’s monitoring experience and       training records.
      遵从法规及指南 Compliance & Guidelines
      医疗器械临床试验规定
      心血管支架临床试验指南
      研究启动及研究者会议  Study Start Up and Investigator Meeting
      方案介绍 Protocol Introduction
      项目进度及受试者入组目标 Project Timeline & Enrollment targets
      中心绩效预期 Site performance and quality expectation
      临床前访视 Pre-Study Qualification Visits
      符合方案要求的中心研究者资质及经验审核Appropriate expertise of Investigators
      清楚方案要求及要点 Trial protocol and procedure requirements
      科室团队具备临床研究经验 Clinical study experience of the team member
      符合法规和方案要求的硬件设施条件 Facilities that meet the regulatory and protocol requirements
      患者群可满足研究入选数量要求 Adequate patient poor for recruitment
      方案和研究流程介绍Protocol requirements and study procedures introduction
      CRF填写培训 CRF filling guidelines
      疑问解决 Queries resolution
      严重不良事件报告 SAE reporting procedures
      原始病历溯源 Source Document Verification
      中期访视 Interim Monitoring Visits
      方案依从性、合规性核查 Conducting in accordance to the protocol, procedures and regulations strictly
      不良事件合规性汇报 Checking if SAEs was reported properly
      CRF表正确填写CRF was completed with accuracy
      严重不良事件报告 SAE reporting procedures
      原始病历溯源 Source Document Verification
      关闭访视 Close-out Visits
      完成遗留监查工作及相关文件 Complete the remaining monitoring activities and document
      整理文件夹至完整 Complete the ISF binder
      文件夹建立及更新  Binder
      研究文件夹Trial Master File (TMF)
      研究者文件夹ISF
      中心启动 Site Initiation Visits

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