​​​​​​​Biostatistics

The international staff framework of ShujuMetrics biostatistics department is extremely efficient.

Biostatistics Team 

With many years of experience creating and analysing eCRF, SDTM,

and ADaM datasets, ShujuMetrics has a first-class staff and expert systems

in place for clinical biostatistics. ShujuMetrics biostatistics team has gained

international acclaim from clients for consistent and impeccable service in

biostatistics.  All ShujuMetrics biostatistics staff members graduated from

top national universities and have strong educational and industry backgrounds.  

Biostatistics Services

  • Statistical Analysis  
  1. Draft the statistical chapter in both of clinical study synopsis and protocol
  2. Experimental design in clinical trial projects
  3. Calculate the sample size and test performance
  4. Create randomized blind form
  5. Create statistical analysis plan
  6. Strategical inquiry of statistical analysis (including interim analysis, the final analysis, safety comprehensive analysis, effectiveness comprehensive analysis, and consolidation analysis)
  7. Perform sensitivity and exploratory analysis
  8. Provide statistical support for Data and Safety Monitoring Board (DSMB)
  9. Draft clinical/statistical comprehensive report
  10. Evaluate and analyze drug safety
  11. Support FDA/EMA submission including NDA, ISS, ISE and IND updates
  12. Pharmaceutical economic research
  13. Meta-analysis service

  •  Statistical Programming
  1. Create standardized data sets and analysis of the special data set (according to the standardization of CDISC standards or customer preference)
  2. Statistical Table, Listing and Figures (TLFs) programming services
  3. Generate and analyze integrated datasets (ISS and ISE)
  4. Data validation, including edit checks
  5. Preparation of e-submission package for FDA/EMA including programs, xpt datasets, TLF, document definition
  6. Consulting service – internal training and outsourcing available
  7. SAS Programmers available to work on-site with client
  8. Double-programming to ensure quality
  9. Semi auto / quick turn-around time