Insightful Corporation, a leading provider of software solutions for analysis of numeric and text data, announced two turnkey solutions for clinical and pre-clinical data managers, analysts and IT professionals supporting clinical reporting and validated statistical data analysis. The solutions are based on S-PLUS 6.2, the new release of the widely used S-PLUS statistical and graphical analysis software. The S-PLUS Validation Solution provides on-site validation for S-PLUS software, meeting 21 CFR Part 11 and GxP standards. Insightful's S-PLUS Clinical Reporting Solution delivers a validated system for tabular and graphical reporting on pre-clinical and clinical studies.
"Insightful's S-PLUS Validation and Clinical Reporting solutions meet industry demand to perform rigorous statistical analysis and provide rich tabular and graphical reporting in a validated production environment, addressing 21 CFR Part 11 and GxP requirements," said Andreas Krause, senior statistician, Biostatistics and Statistical Reporting at Novartis Pharmaceuticals. "The release of S-PLUS 6.2 provides S-PLUS users with simple- to-use batch processing, verbose logging and XML-based reporting capabilities to supplement the powerful graphical and exploratory data analysis capabilities for which S-PLUS is well known."
Insightful solutions are providing a platform for validated statistical analysis and reporting in the heavily regulated pharmaceutical industry. Insightful's S-PLUS Validation Solution provides a proven process for testing installation, operation, security, functionality, and performance of S-PLUS software at customer sites. The solution allows researchers to spend more time performing data analysis to make important discoveries and provides IT staff with a validated and qualified software installation. Insightful's Clinical Reporting Solution is a flexible, customizable solution for report generation. The solution provides a tabular and graphical summary reporting framework for a wide variety of pre-clinical and clinical studies including bioequivalence, dosing and drug interaction studies. Data managers can design and implement statistically comprehensive and flexible reports directly from S-PLUS while complying with standards such as 21 CFR Part 11 and GxP. Standardized reports can be created and automated easily using the new S- PLUS 6.2 XML library that supports .PDF, .RTF, HTML, PostScript, Microsoft Word, PowerPoint and other reporting formats. The solution simplifies report construction by customizing the S-PLUS user interface to meet specific needs of the pre-clinical and clinical data management and analysis teams.
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