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Solutions for Clinical Pharmacology

As a clinical pharmacologist, you handle trial design, analysis, interpretation and report writing for clinical and regulatory submissions. You develop clinical pharmacology sections of clinical protocols and clinical development plans. You analyze PK/PD data from phase I-IV clinical studies. You write and provide support for clinical protocols, investigator brochures, and clinical pharmacology sections of INDs and or NDAs.

Pharsight® helps leverage your understanding of PK/PD principles and hands-on experience in the conduct and analysis of clinical pharmacology studies with software and consulting services for secure PK/PD data management, improved trial design, streamlined report production, modeling, trial simulation, and drug attribute visualization.

  • Optimize dose and treatment regimen for the greatest possible therapeutic benefit to patients.
  • Create more informative trial protocols with modeling and simulation tools.
  • Increase the availability and value of your study data by housing it 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 data management, analysis, modeling, reporting and collaboration.
  • Plan trials and evaluate market position with Pharsight’s software and expert consulting in modeling, simulation and strategic decision-making.
  • 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 Clinical Pharmacology

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

WinNonlin — Industry-standard PK/PD modeling, analysis and simulation tool.
WinNonlin Validation Suite™ — Streamlines your on-site validation of WinNonlin.
IVIVC Toolkit™ for WinNonlin—Enables the use of WinNonlin for in-vitro / in-vivo correlations.
WinNonMix® — Population PK/PD modeling and simulation tool.
Trial Simulator™ — Computer assisted clinical trial design and simulation software.

Benefits:

  • Save time with user-friendly, scriptable, regulatory-compliant PK/PD analysis.
  • Save time and effort with automated WinNonlin validation.
  • Leverage WinNonlin for powerful IVIVC exploration, development and team collaboration.
  • Explore population effects using sparse or rich datasets.
  • Optimize treatment regimens and inclusion/exclusion criteria.
  • Quantify uncertainty in dose response and trial results.
  • Simulate and optimize trial designs before committing funds and subjects.

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 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:

  • Secure data warehousing for critical early drug development data and analysis results from Phase I, ADME, toxicity, drug metabolism, and PK and PK/PD research.
  • 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.
  • Fast, uniform analyses and reports through automation and templates.

 

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