Using PKS™ Reporter

PKS™ Reporter is a Microsoft Word add-in for creation, maintenance, and electronic signature of clinical and pre-clinical study reports. PKS Reporter provides a link to the Pharsight® Knowledgebase Server™ (PKS), so that reports can be stored securely, and updated automatically with the latest study data and analyses.

Secure Report Storage and Version Control

PKS Reporter saves report documents to PKS, Pharsight's solution for electronic data management, for secure document storage and version control.

Import of Secure Study Data

PKS Tags, inserted into a report document, link to study data stored in PKS to provide automatic import of raw data, plots, analysis results and more.

Update Reports to Reflect the Latest Study Data

PKS Reporter tracks the status of report content relative to its source data in the PKS database. PKS Reporter can update tags in a PKS Reporter document, automatically loading the most-recent changes in the PKS database.

Report Templates

PKS Reporter facilitates the use of templates that hold standardized report formatting, text, graphics, and PKS placeholder tags for future study data.

Electronic Signature of Reports

PKS Reporter's support for electronic signatures provides the technical controls that are required by FDA US regulation 21 CFR Part 11.