Pharsight PMx Workbench: Secure, Regulatory Compliant Workflow for Pharmacometrics
The PMx Workbench provides a secure, regulatory compliant workflow for pharmacometrics through the integration of a PK/PD data repository (PKS™) and an open analysis platform (Phoenix®). The PMx Workbench offers modeling teams the ability to work collaboratively on pharmacometrics projects; it allows an organization to create a knowledge base of modeling projects and to later search and query by metadata; and it links data sources with final analysis, notifying users of any change in the underlying data and offering traceability between inputs and outputs. Most importantly, the PMx Workbench is a mature platform built on an open architecture, giving each company the ability to customize to meet the needs of their specific workflow.
The PMx Workbench provides a central repository of time-based PK/PD data, models, workflows, control files, output, plots and tables with robust version control and an audit trail. It also provides access to the most commonly used tools for pharmacometrics, such as NONMEM, R, SAS, S+, Xpose and PsN. The architecture is based on an open .Net API to allow users the flexibility to further extend this toolset as required to meet the needs of each user community. The PMx Workbench can be connected to compute grids and clusters to queue jobs for remote execution.
The PMx Workbench offers users the ability to pre and post process data sets using data management tools built into Phoenix or via interaction with third party tools. The entire collection of data and files associated with an experiment are stored as a single Phoenix project file for simple portability of an entire modeling and simulation project.
Pharsight Deployment Services can support the implementation of the PMx Workbench based on best practices gained from over 25 PKS implementations. The implementation process starts with understanding each organization's specific business/scientific requirements and technology infrastructure. Pharsight's experts in project management, PK/PD modeling and software programming will then prepare a customized deployment plan that meets the needs of each client. Pharsight will then apply a proven methodology to support the deployment of the PMx workbench in a regulatory compliant manner through a tight interaction with the client's internal team.
Benefits
- Create a global, centralized knowledgebase of all pharmacometrics projects for re-use and sharing.
- Develop reusable graphical workflows that link to commonly used PK/PD modeling tools.
- Send compute jobs to remote grids and clusters.
- Create standardized outputs for consistent reporting.
- Supports 21 CFR part 11 compliance with a full audit trail, version control, and electronic signatures.
- Traceability between all inputs and outputs.
- Refresh notification if underlying data is not up-to-date.
- All data, models, control files, plots, tables and outputs stored as a single project file.