Biostatistics Analysis

GreenLight Clinical’s Biostatistics team provides clinical and pharmacokinetic/pharmacodynamic analyses to industry and government/academic organisations. Focusing primarily on data generated from clinical trials we also offer advanced data presentation services that translate raw numbers into a considered and cohesive reflection of outcomes.

Our suite of integrated services enable our clients to both implement their trials as well as use the generated data for high-quality analysis and detailed submissions.

Clinical Trial Implementation

  • Sample size/power calculations that enable authoritative study design
  • Randomisation procedures for effective group comparisons
  • Optimal experiment/study design
  • Clinical trial simulation and hypothesis testing (i.e. inter-group comparisons)

Analysis & Submissions

  • Statistical analysis plan (SAP) and protocol writing
  • Statistical data modelling
    – regression
    – general linear modelling
    – non-linear modelling
    – mixed-effects modeling
    – survival analysis
  • Pharmacokinetic/pharmacodynamics analysis
    – non-compartmental analysis (NCA)
    – population non-linear mixed effects modelling and simulation
  • Data review and quality assurance
  • Data presentation for regulatory submissions (e.g. tables, figures, listings)
  • Data summaries, reports and publications
  • Interpretation and plain language communication of results for general audiences

All statistical analyses are undertaken with programmed reproducible methods using industry standard software packages including SAS, R, WinNonlin and NONMEM. All work is undertaken and stored in a secure, dependable and fully backed-up computing environment and in accordance with our own SOPs and work instruction documents.