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Solutions for Biostatistics

As a biostatistician, you assist in PK/PD study design, provide statistical input for the planning, analysis, and reporting of multiple clinical and preclinical projects. You prepare analysis plans that strive to produce more informative trials, perform exploratory analysis of data, and write statistical reports. You seek to continuously improve the quality of R&D decisions.

Pharsight® provides a powerful combination of software technology and strategic consulting services to speed and standardize your analysis and reporting tasks, improve your confidence in R&D strategy decisions, and ensure that all analyses are conducted using a secure PK/PD repository supporting a regulatory-compliant workflow.

  • Improve workflow by automating common and repetitive analyses for fast, uniform output.
  • Optimize the dose and treatment regimen for the greatest possible therapeutic benefit to patients.
  • Maintain your study data in a regulatory-compliant repository linked dynamically to your analysis tools including SAS, NONMEM®, WinNonlin®, and S-PLUS®.
  • Spend less time manipulating data, building models, and producing results.
  • Improve the productivity of biostatistical analysis, reporting and collaboration.
  • Learn to apply Pharsight technology and modeling and simulation methods through courses offered on our site or yours.

Pharsight is the established leader for strategic drug development consulting, analytical modeling tools, drug attribute visualization, and PK/PD data management.

Products and Benefits for Biostatistics

Strategic Consulting Services

A global team of scientific experts with a focus on using quantitative models to improve drug development strategy and decision-making.

Benefits

  • Optimize clinical development programs to maximize therapeutic potential, R&D productivity and commercial value.

Analysis

Trial Simulator™ — Computer assisted clinical trial design and simulation software.

Benefits

  • Optimize treatment regimens and inclusion/exclusion criteria.
  • Simulate and optimize trial designs before funds and subjects are committed.

Visualization

Drug Model Explorer® (DMX®) — Visualization and communication tool to explore and compare model-based product profiles.

Benefits

  • Assess modeled drug attributes and uncertainty versus the competition.
  • Visualize and communicate “knowns” and “unknowns” within and across development teams.

Data Management and Reporting

Pharsight® Knowledgebase Server™ (PKS™) — Enterprise Data Management and Reporting system for secure storage and change tracking for PK/PD data and analyses.
PKS Reporter™ — Automated system for report authoring, updating, and review/approval.
WinNonlin® AutoPilot™— Software application for WinNonlin that automates creation of clinical PK analysis outputs for standard reports.

Benefits

  • Streamline and standardize data management, analysis, reporting, QA and validation.
  • Share PK/PD data, and store and run SAS or NONMEM analyses using the PKS Clients.
  • Support compliance with internal SOPs and standards as well as regulatory requirements.
  • Speed frequently-used analyses and reporting through automation and templates.

 

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