Biostatistics

 

Our team of highly skilled Biostatistics Project Leaders and Statistical SAS Programmers provides sponsors with high quality statistical services.
We can handle projects from Phase I to Phase IV and surveys in accordance with regulatory requirements.

 

 

Our services in Biostatistics:

  • Advice on Protocol Design
  • Statistical Methodology
  • Sample Size Estimations
  • Consulting for Product Development
  • Development of Protocol Statistical Sections
  • Randomization List
  • Statistical Analysis Plan (sponsor or Biotrial templates)
  • Data / Analysis Review Meeting
  • SAS® Programming
  • Derived Analysis Data Sets (ADaM standards) 
  • Statistical Results and Appendices (TLFs)
  • Interim Analysis
  • Data Monitoring Committee (DMC) and Development Safety Update Report (DSUR) Support
  • Independent Double Programming
  • Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) Analyses
  • Statistics for PK and PK\PD analyses
  • Statistical Reports
  • Input into submission files

 

For our statistical work we use among others SAS® and R®.

Our biostatistics team is well-experienced in the following analyses among others:

  • Mixed models
  • Analysis with repeated measurements
  • Equivalence/non-inferiority analysis
  • Multiple Comparisons
  • Survival Analysis
  • Non-Parametric Analysis
  • Analysis of Categorical Data
  • Dose Proportionality and Steady State Analysis

 

Our statisticians are highly qualified individuals with at least the following credentials:

  • Ph.D. in Mathematics or Statistics
  • Master’s degree in Applied Mathematics or Statistics
  • At least 5-year experience in pharmaceutical companies or CROs

 

For more information on our Biostatistics Department and activities please contact us: contact@biotrial.com