EN
We provide comprehensive operational services for Phase I-IV clinical trials, including trial project management, clinical site management, clinical trial monitoring, data quality management, investigational product management, document management, and risk and quality management. The team has extensive clinical operation experience, collaborating with over 700 clinical centers to fulfil the needs of push project fast forward.
Development of trial operational strategy / project management plan
Progress monitoring and control
Overall project progress and third-party vendor management
Risk / budget / enrollment management
Quality control and training
Clinical center screening
Clinical center monitoring
Investigational drug/sample management
Source data review/verification
Data cleaning/ clinical center close-out/submission of final reports
Risk assessment and prevention
Back up plan
Data collection and entry
Data cleaning and analysis
Data quality assurance
Procurement and distribution management of investigational drugs
Drug compliance monitoring
Preparation and organization of trial documents
Regulatory compliance assurance
Protocol discussion meetings/SMC meetings/Data review meetings/Trial summary meetings
Other key meetings
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