Products

APT Software Library

Statistical Programming Tools

A key component of the clinical trials process is the accurate and timely programming of statistical results. We believe this is best accomplished using reusable reporting software modules. PharmaStat uses the APT™ (Analysis Programming Tools) Software Library for statistical reporting. The software can enhance the productivity and quality of statistical reports and give the programmer the flexibility to create many of the reports recommended in ICH E3: Structure and Content of Clinical Study Reports.

The reporting process benefits in the following ways:

• Enhanced productivity by statistical analysts
• Greater reliability and confidence in reported results
• Consistency of look and appearance
• Publication ready output tables in rtf, html, pdf, or ascii

APT is a suite of SAS™ macros that produce statistical reports from clinical trials
data. The APT library runs under SAS™ Versions 8.x and 9.x on Windows and Unix. SAS/BASE and SAS/STAT are required. The statistics are derived
directly from SAS statistical procedures. The software is designed to be used by
SAS programmers and statisticians.

The types of statistics produced include:

• Counts and percentages of observations by category
• Univariate descriptive statistics
• Counts of unique subjects by category
• P-values for linear models, frequency counts, nonparametric comparisons, and survival analysis
• Difference in means or proportions between groups and confidence intervals for the difference

Documentation, Training and Support

A detailed user manual is included with examples demonstrating every aspect of the software. On-site training for a fast start can be provided. Implementation services includes a comprehensive validation solution for the APT tools. A complete set of documentation is provided (validation plan, IQ, OQ, PQ, traceability matrix, and validation report).