Data Management of Mandatory Adverse Event Reporting for Peramivir Emergency Use Authorization

Client: U.S. Food and Drug Administration (FDA)

Client/study focus and needs: We provided adverse event data management services in support of the Peramivir Adverse Event Data Management Program (PAEDMP). We established an adverse event database; conducted the receipt, tracking, and data entry of adverse event reports; investigated and collected follow-up information from health care professionals regarding the reported adverse events; electronically reported new and follow-up information to FDA; performed data analysis; and identified potential safety signals.

Our customized approach: We created a customized standard operating procedure detailing the processes for the receipt, assessment, coding, follow-up, and electronic submission of individual case safety reports to FDA; developed data collection forms; created signal detection/trend analysis reports; and customized the ARISg™ safety database, a commercially available state-of-the-art electronic safety database management system, to meet FDA requirements. We provided regular administrative reports on the number of adverse event reports received and submitted to FDA.