Solutions Support Biopharmaceutical Industry Need For Validated Statistical Data Analysis and Reporting Meeting Stringent 21 CFR Part 11 and GxP Standards
SEATTLE--(BUSINESS WIRE)--Jan. 15, 2004-- Insightful Corporation (Nasdaq:IFUL - News), a leading provider of software solutions for analysis of numeric and text data, today 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.
The S-PLUS Validation Solution and Clinical Reporting Solution are available now.
Insightful Corporation (Nasdaq:IFUL - News) provides enterprises with scalable data analysis solutions that drive better decisions faster by revealing patterns, trends and relationships. The company is a leading supplier of software and services for statistical data analysis, data mining and knowledge access enabling clients to gain intelligence from numeric and text data.
Insightful products include S-PLUS®, Insightful Miner, StatServer®, S-PLUS Analytic Server® and InFact®. Insightful consulting services provide specialized expertise and proven processes for the design, development and deployment of customized solutions. The company has been delivering industry-leading, high-ROI solutions for 17 years to thousands of companies in financial services, pharmaceuticals, biotechnology, telecommunications, manufacturing, plus government and research institutions.
Headquartered in Seattle, Insightful has offices in New York City, North Carolina, France, Switzerland, and the United Kingdom with distributors around the world. For more information, visit www.insightful.com, email firstname.lastname@example.org or call 1-800-569-0123.
Note to Investors - Forward Looking Statements
This press release contains forward-looking statements, including statements about the capabilities of our software and acceptance of our products in certain vertical markets. Forward-looking statements are based on the judgment and opinions of management at the time the statements are made. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Actual results could differ materially from those expressed or implied by the forward-looking statements for a number of reasons, including, without limitation, the risks associated with errors or defects in our software and the risks associated with our ability to gain market acceptance of our products. More detailed information regarding these and other factors that could affect actual results is set forth in our filings with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2002. You should not unduly rely on these forward-looking statements which apply only as of the date of this release. We undertake no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release or to reflect the occurrence of anticipated events.
Insightful, the Insightful logo, "Insightful intelligence from data", S-PLUS, StatServer, InFact and S-PLUS Analytic Server are registered trademarks of Insightful Corporation. Other trademarks mentioned are the property of their respective owners.
Judy McOstrich, 206-283-8802 ext. 356
Source: Insightful Corporation