Clinical Monitoring and Project Management

CR Medicon's clinical operations service has a staff of nearly 50 and continues to expand rapidly. Our members have rich Phase I-III clinical, BE and medical device research experiences. We also have deep and extensive collaborations with well-known clinical trial institutions and domain experts around China. As a basis of our complete project management process, we have on-site auditors in many cities across China. In accordance with the clinical trial protocol, we strictly follow the SOP operating procedures, effectively control the project progress, save costs for our clients, and ensure the smooth implementation and timely completion of the project.

Services

Provide Phase I-III, IV and medical device pre-market and post-market clinical audit and project management services, including:

  • Clinical center screening    
  • IRB submissions
  • HGRAC (Human Genetic Resource Administration of China) submissions
  • Clinical center initiation    
  • Routine inspection     
  • Open-label inspection
  • Clinical center closure    
  • QC      
  • Independent Data Monitoring Committee (DMC) organization and meetings
  • 3rd-party vendor management

Clinical operations team locations in China:

  • Changchun
  • Beijing
  • Shijiazhuang
  • Nanjing
  • Shanghai
  • Wuhan
  • Chengdu
  • Guangzhou

Advantages

  • Our quality control system strictly follows ICH-GCP standards
  • All staff members have the professional background in medical and pharmaceutical fields, more than half with master's or higher degrees
  • All project managers have 5-15 years of clinical trial industry experience
  • All CRAs come from well-known CRO companies, with clinical trial experience in pharmaceutical products.
  • Excellent staff stability (churn rate less than 10% in 2018)
  • Our team has outstanding track record in new drug Phase I-III trials, BE and medical device project management
  • Experience in managing projects in emerging categories, including immuno-oncology, cell therapy, biosimilars, etc.
  • Jointly built three Phase-I clinical trial centers, with a total beds of more than 200
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