QPS China - Shanghai

• QPS China in Shanghai is a GCP-compliant CRO that performs data management and biostatistics.
• Established in 2018, the facility encompasses 800+ square feet.

Core Competencies

• Data management and biostatistics compliant with China FDA, Taiwan FDA, US FDA, and EMA registration.
• SAS, WinNonlin, OpenClinica®, and RAVE.
• CDISC-compliant system

Experience

• Head of the facility has 10+ years of experience in the field.
• Data Managers and Biostatisticians with multiple years of relevant experience.

Quality Management System

• SOP administration.
• Employee training program/qualifications.
• System validation, IQ/OQ/PQ.
• TMF archives