Drug Safety Reporting Solution, PvEdge, efficient and compliant
PvEdge, a safety reporting tool provides comprehensive analysis of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy). 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.
Phamacovigilance since beginning has been a compliance driven activity, wherein your regulatory compliance determines your company’s risk assessment scores. PvEdge, allows scheduling alerts for expedited cases, follow up cases and PADER/PSUR report submissions to meet regulatory timeline compliance.
At present, 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.
In presence of considerable divergence in global safety reporting requirements, PvEdge standardises key aspects of safety reporting and promises efficiency of global safety data management & electronic communication.
Global regulations are harmonizing and moving towards ICH and ISO standards with the need of consistently identifying medicinal products across geographies. This in recent times has come up as an EMA regulatory requirement for xEVMPD, with the objective of clear identification of medicines in reports. PvEdge’s xEVMPD solution meticulously addresses this regulatory requirement, generating xEVPRMs per schema laid down in accordance with Article 57 (2) requirements.