CLINICAL OPERATION
Clinical Operation
TALENT provides full-service clinical trials for pharmaceutical and medical device. With our rich clinical trial experience and electronic system management, such as CTMS and eTMF, TALENT provides clinical trial services that meet the needs of clients best in terms of price, quality and schedule.
Comprehensive clinical quality assurance system
We provide clinical operation service for
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Medical Document Writing
- Clinical Trial Protocol
- Investigator Brochure
- Informed Consent Form
- Case Report Form
- Clinical Study Report
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Clinical Trial Planning
- Site Feasibility Assessment
- Competent Authority Application
- IRB/EC Application
- Clinical Trial Agreement
- EDC Building
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Clinical Trial Operation and Monitoring
- Project Management
- Safety Management
- Data Management
- SAE Reporting and Management
- Statistical Analysis
- Third Party Audit/ Competent Authority Inspection
