PvEdge safety database 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 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 safety database 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 safety database offers complex data analysis and querying of safety data sets, allowing quantitative and qualitative signal detection, resulting in better risk-benefit profiling of drugs.
PV Document management system provides a user-friendly, easy to implement and use contemporary document management system to create, review, approve, manage and archive documents electronically. It provides improved collaboration, workflow efficiency and compliance.