Comprehensive Biostatistical Services Deliver Timely
and Accurate Data Analysis

Sound data analysis is achieved through a comprehensive understanding of biostatistics, FDA guidelines, study objectives, issues and data, along with tight quality control procedures. Working as your partner, Synteract’s expert biostatisticians will work closely with you to determine the ideal methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our programmers can create custom presentations, tables, listings, figures, and reports optimized for your unique study designs. Rest assured that team members stay current with industry standards, such as CDISC naming conventions required for submissions to the FDA.

Data analysis includes:

• Consultation on study design, sample-size estimation, and statistical analysis planning
  
• Study randomization
  
• Analysis programming
  
• Interim/sequential analysis
  
• Data integration – ISS/ISE
  
• Integrated report preparation
  
• Integrated summaries of safety and effectiveness
  
• Dynamic randomization – Internet or wireless
  
• Preparation of SAS® data for FDA
  
• CDISC data compliance and conversion
  
• Expert data analysis
  
• Data monitoring committee
  
• Data browse/Query (Integrated Review™)