Enhanced Clinical Data Analysis & Reporting Using S-PLUS 6.2

Presented: November 19, 2003
Speaker: Dr. Michael O'Connell, Director, BioPharmaceutical Solutions, Insightful Corporation

Listen to the archived webcast.

Download related article and webcast presentation in PDF:

• Webcast Presentation
• S-PLUS Validation Solution
• S-PLUS Clinical Reporting Solution
• Insightful and S-PLUSProduct Family—Compliance with 21 CFR Part 11, GxP and Related Software Validation Issue

Abstract
Data management and analysis of clinical and pre-clinical studies involves an enormous effort on the part of biostatisticians, S-PLUS and SAS programmers. There are many FDA-required studies; and efficient trial design, rigorous statistical analysis and sound clinical inference are required at all stages. In addition, substantive regulatory pressures mandate a validated data management and analysis environment. This must be maintained in parallel to a creative statistical and graphical analysis sand-box, that is needed to understand and demonstrate clinical effects throughout the project teams. This seminar describes clinical data analysis and presentation using S-PLUS including:

• Validated analysis. Batch analysis jobs and scripted error checking of verbose log files.
  
• Tabular and Graphical Reporting. Automated analysis and reporting for pre-clinical (and clinical) studies.
  
• Advanced Statistical Analysis. Regression, survival and advanced analysis of clinical data.
  
• Improved Clinical Trial Design. Group sequential clinical design methods.
  
• Complementing SAS. Providing seamless statistical analysis and visualization for data managed and transformed using SAS.
  
• Knowledge Sharing/Deployment. Advanced visualization with S+Graphlets and Web-based deployment through StatServer for improved collaboration and information sharing between project teams and key decision-makers.