Our flexible software system designed to support pharmacovigilance business processes and technical services case handling practices, while meeting the associated company safety and world-wide regulatory reporting requirements. Used by pharmaceutical companies, CROs, and Pharmacovigilance outsourcing service providers, the software can record, report, and analyze clinical trial and post-marketing adverse events. Ensures the efficient and accurate intake of PV cases and seamlessly submit safety data to the FDA, EMA or other regulatory authorities worldwide via the supplied E2B compliant gateway. Make controlled assessments and apply standardized coding, all while maintaining complete regulatory compliance. All common single case and aggregate reporting formats are accessible.