Results, Interpretation & Regulatory Support
Results and Validation
Accuracy and quality is the key of everyday BSSI work. At BSSI, we provide sound statistical analysis and solid results to our clients. Every analysis dataset (ADS), statistical program, PowerPoint presentation, and statistical analysis report (SAR) is subject to strict and prudent validation by another member of our analysis team. During the validation process, the author of the statistical program, presentation, or SAR communicates effectively with the validator to ensure accurate delivery of every statistical analysis output. Whenever necessary or requested by the client, independent programming can be performed.
Reporting & Interpretation
We believe that proper interpretation and reporting form an indispensable part of any complete statistical analysis. At BSSI, not only do we deliver tables, figures and listings (TFLs) that you would expect from the common CROs, but we also provide executive summaries, detailed statistical analysis reports (SARs), results visualizations that can be easily converted into show cases for marketing purposes, and PowerPoint presentations at the request of our clients. Statistics being our tools, we dissect each project with careful inspection of data and selection of statistical methods, and connect all the dots with biological and medical knowledge to provide our clients meaningful interpretation of statistical results.
BSSI has extensive experience going alongside clients in their interactions with Federal agencies such as FDA, JVAP and BARDA. We assist clients in preparing Statistical Analysis Plans (SAPs) and Statistical Analysis Reports (SARs) for submission to these agencies as well as contributed relevant statistical sections to submission packages. We have experience representing clients in meetings with the agencies.
We have worked as subcontractors and contractors on government projects and have experience with scoping statistical analyses, writing progress reports, and developing novel approaches to meet client needs.