Innovative Analytics
Your Date...Our Experience..Sound Decisions...
Fotolia_99629869_Subscription_XXL.jpg

Clinical Biostatistics

Qualified to design and support your study in the most efficient manner possible.

Our extensive experience includes:

  • Exploratory development - biomarkers, quantitative imaging, pharmacogenomics
  • Proof of Concept Studies
  • TQTc analysis
  • Adaptive study design
  • Futility analyses
  • Study resizing
  • FDA & International regulatory face to face meeting experience
  • Data Safety Monitoring Boards
  • PK/PD modeling (WinNonlin) and analyses

Available Clinical Statistics services include:

  • Provide input for study design and clinical trial protocol development
    • Innovative/adaptive designs
    • Statistical Analysis Plans (SAP)
    • Biomarker, novel endpoint, device, and diagnostic development and validation
  • Clinical study analysis and statistical reports
    • Traditional primary safety/efficacy analyses for phase I-IV studies
    • Receiver Operating Characteristic (ROC) analyses for diagnostics
    • Exploratory analyses – data mining, decision trees
    • PowerPoint presentations of trial results
    • Participation on Data Safety Monitoring Committees
  • Clinical program support
    • Assist in product registration and defense activities
    • Provide statistical analyses for and interpretation of publications
    • Conduct meta-analyses

Tools:

  • Statistical Analysis
    • Standardized Output Catalog
      • SAS® / SAS® Genetics
    • nQuery® Power/Sample Size Analysis/Randomization codes
    • East® for interim analysis planning
  • Exploratory Analysis
    • Spotfire®
    • CART®
    • MedCalc®
    • East®
    • ROC Analysis