A Submission Development Environment to Support SAS Programming and Related Activities During Clinical Data Analysis

Pharmaceutical companies conduct many activities during the statistical analysis of their clinical data. This is one part in their larger process of collecting, managing, analyzing, and presenting all this clinical data (safety and efficacy). Many companies now provide considerable system support for the early part of this larger process, (i.e., the data collection and management), and for the later part when the New Drug Application (NDA) document is published and presented to a regulatory agency in electronic form. But much less has been done to support the work involved in the statistical analysis of the data using SAS Software, particularly Base SAS and the Macro Language. I discuss automated, integrated support for the statistical data analysis in this paper. I call this support a Submission Development Environment. An automated, integrated environment for this work is surely a challenge, but it offers much potential payoff if it can be achieved