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WinNonlin® AutoPilot™ — Streamlining Routine Clinical PK Analyses and Reporting

WinNonlin AutoPilot is a configurable software application for WinNonlin® that automates the creation of presentation-quality clinical pharmacokinetic (PK) analysis outputs from study data to be used in standard reports. Using WinNonlin AutoPilot, companies can vastly improve their productivity while improving the quality and consistency of analyses and reports.

Pharsight offers software evaluation licenses to commercial organizations

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WinNonlin AutoPilot operates with Pharsight’s enterprise PK data management system, Pharsight Knowledgebase Server™ (PKS™), and can also be used independently of PKS.

AutoPilot orchestrates PK analyses by selecting input data from a local file system or PKS, and then directs WinNonlin to perform analyses and produce report-quality tables, figures, and text output (e.g., in SigmaPlot®, Microsoft® Word and Excel®) for regulatory submissions and interim reports. AutoPilot supports all relevant study types (crossover and parallel study designs) and works with wide and stacked datasets.

AutoPilot provides the infrastructure and tools to manage and effectively automate common or repetitive data transformations, PK analysis, and creation of report-ready tables and graphs. Because these outputs must reflect the requirements and SOPs of each research organization, AutoPilot provides an administration module that allows extensive configuration of formatting and business rules that apply in the generation of these analyses. The resulting customer-defined configurations do not require changes to the underlying computer code, and are stored in a settings file that enables clear communication of standards and immediate use across the organization.

Used in conjunction with the PKS and PKS Reporter™, WinNonlin AutoPilot provides standardized, regulatory-compliant, secure and automatic generation of routine analyses and reports. AutoPilot-generated output saved to the PKS can populate standardized report templates in PKS Reporter, enabling automatic report updates and secure review and approval with electronic signatures.

Used independently of PKS, WinNonlin AutoPilot can provide significant return on investment through productivity and quality improvements in PK analysis and reporting. (see "Releasing the Human Spirit in Developing Drugs" for a case study of how a top-ten pharmaceutical company increased clinical PK productivity using automation).

Benefits

  • Capture and implement best practices and business rules within a department and across sites.
  • Standardize content and formatting of analyses and reports to reduce authoring/review effort and improve consistency and quality.
  • Automate analyses with computer-based scripts to ensure repeatability and traceability.
  • Decrease reporting backlog and submission delays, and increase ability to respond to requests for interim analyses.
  • Free-up PK scientific resources to focus on trial simulation, population PK modeling and model-based drug profile exploration.
  • Extend PK automation gains to regulatory-compliant workflows and report generation through integration with PKS and PKS Reporter.