Flexible, Precise Data Management and Statistical Analysis Solutions
International standards, covering the entire clinical research process
SDM’s data management team adheres to the industry standards and established operating procedures. We are committed to providing quality data management solutions for clinical development and regulatory submissions.
• Hundreds of clinical trial data management projects
• Expertise across therapeutic areas such as oncology, infectious diseases, vaccines, autoimmune disorders, medical devices and more
• Experience with multiple EDC+RTSM system setups for both domestic and international projects
• Experience in multiple countries and regions
• Proven record of high-quality, on-time delivery with the ability to quickly respond to urgent needs
Comprehensive Quality System
SDM’s statistical and data management quality system follows ISO 9001 quality management standards, clinical trial quality management standards, ICH guidelines, and NMPA data management guidelines. Our focus is on providing meticulous, professional, scientific, and efficient services through the establishment of a robust quality management system.
• Over 100 data management SOPs and templates
• Quality management system tailored to multiple global regulatory requirements
• Data health status and project risk monitoring system
• Standard database creation based on CDASH
• Comprehensive training system for data management, project management, and therapeutic areas
• Proprietary coding platform and performance metrics calculation tools
Specialized Teams
SDM’s data management team consists of serval segments: BE, early-phase clinical research, phase II/III registration studies, IIT, medical devices, etc.
Our core team members are graduates of renowned universities and bring extensive experience.
Learn more about SDM’s flexible, reliable and efficient data management and statistical programming solutions.
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