Drug Safety Reporting Solution, PvEdge, efficient and compliant
PvEdge, a safety reporting tool provides comprehensive analyses of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy, Vaccine). It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively caters to all risk management requirements on a single platform, ensuring global regulatory compliance. The drug safety database allows the risk-benefit analysis of medicinal products taking into account new and emerging information, in the context of cumulative information.
Pharmacovigilance since the beginning has been a compliance-driven activity, wherein your regulatory compliance determines your company’s risk assessment scores. Global regulations are harmonizing towards ICH and PvEdge is compliant with those ICH E2B R3 and GDPR regulations
At present, the focus of pharmacovigilance has shifted from passive data collation and reporting to proactive pharmacovigilance with greater emphasis on Risk-Benefit assessments and Signal Detection. PvEdge offers complex data analysis and querying of safety data sets, allowing quantitative and qualitative signal detection, resulting in better risk-benefit profiling of drugs.