Flexible, Precise Data Management and Statistical Analysis Solutions
International standards, covering the entire clinical research process
SDM’s biostatistics team adheres to the industry standards and well-defined standard operating procedures. We offer full-process statistical analysis services, including statistical monitoring and risk warning based on data simulations. We are dedicated to providing comprehensive statistical analysis solutions for clinical development and regulatory submissions.
Our Experience Includes:
• Hundreds of statistical analysis projects to support different stages of multiregional studies
• Assist in professional research projects
• Extensive experience in communicating with regulatory authorities worldwide
Provide statistical considerations to clinical study design
Serve as a third-party audit for statistical analysis
Presentation and representation to regulatory agencies in the US, EU and China
Ability to perform innovation clinical study design
Authoring ISS/ISE and meta-analysis
Independent statistical teams for Data Monitoring Committees (DMC)
Comprehensive Quality System
SDM’s statistical quality system is built according to ISO 9001 standards, clinical trial quality management protocols, ICH guidelines, and statistical-related guidelines issued by competent authorities to provide professional, scientific and compliant services.
Experienced Team
SDM’s data management team consists of serval segments: BE, early-phase clinical research, phase II/III registration studies, IIT and medical devices.
Staff members are graduates from internationally recognized institutions and are highly experienced with years of services in the sector from INDs to NDAs to support clients with tailored services.
Learn more about SDM’s flexible, reliable and efficient data management and statistical programming solutions.
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