1 会议协助
Conference assistance
2 项目培训会
Project training mee
3 伦理及机构的沟通协调
Communication and coordination with Ethical and Clinical institutions
4 安全性管理报告管理
Safety report management
5 试验文档管理
clinical document management
6 受试者管理
Clinical Subject management
7 试验药物/器械及其物资管理
Drugs/ Medical Instruments and Clinical Supply Management
8 EDC录入/CRF填写及差异解决
EDC/ CRF input and De-differentiation
9 试验标本管理
Specimen management
10 CRA检查工作的配合
Cooperation with CRA on audit
11 申办方或管理部门的稽查和视察的配合和协调
Cooperation and Coordination with Sponsor (on audit) and Regulatory Authority (on inspection)
12 多方沟通及记录
Multi-party communication and communication recording
13 票据管理
Bill management
14 其他
Other
1 稽查
Quality audit
2 项目可行性调研
Feasibility study of the project
3 伦理递交
Ethical submission
4 研究者会议组织
Organization of Investgator Meetings
5 受试者招募
Subject recruitment
6 研究中心信息收集
Information Collection of Research Center
7 研究相关培训
Research related training
8 内部稽查
Internal audit
9 临床试验项目管理
Clinical trial project management
10 试验物资和试验文件管理
Clinical Supply and Document Management
1 专业的临床研究协调员(CRC)配备
Professional clinical research coordinator (CRC)
2 研究文档的管理
Clinical document management
3 受试者招募与管理
Subject recruitment and management
4 研究物资、研究数据管理
Clinical Supply and data management
5 伦理和机构的沟通
Communication with Ethical and Clinical institutions
6 安全信息的管理
Security information management
7 研究中心SOP的建立和完善
Establishment and improvement of research center's SOP
8 研究者及其他参与人员的培训
Training of investigators and other participants
9 协助机构对在研项目的稽查
Assistance to institution's internal audit
10 协助接受NMPA/CDE现场核查
Assistance to NMPA's/CDE's on-site inspections
11 费用协商
Cost negotiation
12 帮助研究中心招揽新的研究项目,挖掘潜在机遇
Assist research institutions in business development and opportunity exploration
13 稽查
Quality audit