Drug Development

CLINICAL DATA ANALYSIS AND BIOSTATISTICS

S-PLUS is the premier statistical software solution for biostatistics and the analysis of clinical data. Comprehensive, validated, rigorous, biostatistical analysis methods are readily available from both a simple point-and-click GUI and simply scripting using the S-PLUS language. A history option in the GUI traps all GUI interactions and an audit trail is thus available from both scripting and GUI analyses. In addition to the 4200 inbuilt statistical functions in S-PLUS, a wealth of specialized functions are available from on-line resources such as StatLib.

Recent events have resulted in increased scrutiny on safety outcomes of pre and postmarketing studies. At the same time, reduced budgets are forcing research directors tomaximize the efficiency with which trial resources are deployed. Insightful's SafetyMiner solution provides both the software and services necessary for risk management,while maximizing the opportunity for success in pre and post marketing studies.

Designing and running FDA-required analytic reports from clinical and pre-clinical studies can be time consuming for biostatisticians and programmers. Insightful's Clinical Reporting Solution provides your organization with a validated, automated, tabular and graphical reporting solution. Faster report generation improves collaboration and provides a strategic time-to-market advantage while adhering to validation guidelines. Insightful's Clinical Reporting Solution supports rigorous, reproducible, validated data analysis and reporting, that complements the interactive S-PLUS exploratory data analysis experience.

The S-PLUS Clinical Pack includes:

• S-PLUS and SAS® Software Graph Library - Trellis and specialized model plot functions in SAS-ready format
  
• The SAS® Software Macro Collection: (a) Individual SAS software macros for calling many S-PLUS functions from within the SAS environment; (b) SAS software macros for managing the S-PLUS environment e.g. line types, colors, plot parameters
  
• Integration in structured environment -Development and production environments
  
• S-PLUS 6.2 XML and CDISC tools: (a) read/write XML in/out of S-PLUS; (b) create, parse and transform XML from within S-PLUS
  
• S-PLUS 6.2 Batch and Log tools
  
• Training on development extensions

The S-PLUS Validation Solution, provides you with a turnkey solution for S-PLUS software validation including the testing, documentation and reporting you require to ensure high-quality information is delivered to key scientists, decision-makers and regulatory bodies throughout the drug development process.

CLINICAL TRIAL DATA MINING

Pharmaceutical companies accumulate large volumes of data during drug development. Secondary analyses of clinical trials data have become increasingly important in understanding safety and efficacy of introduced drugs.

Insightful Miner is a simple-to-use, scalable data mining workbench. Insightful Miner is currently being widely used in clinical trial and claims data mining.

Key applications include:

• Pharmacovigilence, signal detection, safety data mining
• Additional indications
• Identification of sub-populations with enhanced efficacy
• Registries
• Epidemiology and pharmacoeconomics
• Publications and presentations
• Formulary acceptance programs
• Provider experience programs
• Patient outcomes programs

Figure 1: Insightful Miner pipelines for data preparation and analysis in detection of hyperkalemia in composite clinical trial data