Drug Safety Software Adverse Event Reporting

TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure. Drug Safety users can accurately and efficiently record events and products (suspect, company, prior, and concomitant), code terms against industry standard thesauri, conduct seriousness, causality, and listedness/expectedness assessments, and determine reportability of adverse events to appropriate health authorities.

For safety cases that are reportable, TrackWise supports a multitude of standard drug safety reports for paper and electronic reporting to meet expedited and periodic reporting requirements. TrackWise’s electronic reporting platform provides flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities.