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