Ensure the quality of trial execution
◆ Optimize and update department SOP regularly
◆ Strict management throughout the whole process: participate in the protocol review and prepare the medical monitoring plan at the early stage of the trial; perform medical monitoring and provide medical support during the trial; complete summary stage to complete the summary report
◆ Mature project team member training and management process
Highly professional and stable medical team
◆ More than 90% of the medical staff have master's degree or above in clinical medicine, all have many years of hospital clinical work experience and rich clinical trial experience, especially tumor clinical experience
◆ More than 60% team members have more than 3 years of clinical trial medical supervision experience, and than 30% of them have more than 5 years of clinical trial work experience
◆ Customized medical surveillance plan (MMP) and report
◆ periodic summary and analysis of medical verification
◆ CSR auditing
◆ Medical risk management
Protocol interpretation and medical training
Introduction to the field of related diseases
Subject enrollment review
Review scheme deviation
24-hour emergency medical services
Review of clinical data
Medical support for clinical data cleaning
Provide CRF audit
Unblinding medical support
◆ IND application materials
◆ Phase I-IV Clinical Trial Protocol
◆ Risk Control Plan
◆ Investigator's Manual (IB)
◆ Informed Consent Form (ICF)
◆ Clinical trial related materials
◆ Clinical Study Report (CSR)
◆ New drug development consulting service
◆ Product feature analysis
◆ Clinical Development Plan/Strategy (CDP)