CONTEXT:
A client developing a new diabetes treatment needed comprehensive statistical reports for regulatory submission. These included numerous tables, listings, and figures (TLFs) with strict formatting and content requirements, making accuracy and compliance critical.
RESOLUTION:
Our team employed SAS programming to generate high-quality, customizable outputs using the Output Delivery System (ODS). Key analyses included descriptive statistics, ANOVA, and regression modeling to assess drug efficacy and safety. Visualizations were also created to clearly communicate study findings. The ODS framework allowed precise control over the structure, style, and formatting of all deliverables to ensure alignment with regulatory standards.
RESULT:
The reporting solution met stringent regulatory guidelines, enhanced presentation clarity, and minimized the risk of formatting errors. This improved the overall quality of submission documents and supported a smoother regulatory review process.