Epidemiological Studies


RADARS System assists with development of formal epidemiological studies per FDA guidance, FDA Advice Letters, and good pharmacoepidemiological practices. We provide assistance with development of statistical analysis plans to accompany protocol as well as prepare and deliver scheduled study reports as detailed in the study protocol. RADARS® System keeps clients up-to-date with interim status reports to provide current analysis based upon the statistical analysis plan for the post market requirement, primarily for internal use. Early status reports may be descriptive until adequate data is available to perform statistical analyses. We will then review the reports by webinar or in-person to ensure understanding of the results, discuss findings, etc. In addition, RADARS System will review externally prepared materials in relation to the post market requirement study to ensure accurate and appropriate use of RADARS System data and interpretation of the study findings.