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.
Solutions
Post-Marketing Safety Reporting (PMS)
An efficient post marketing ICSR management solution involves the practice of monitoring the safety of a pharmaceutical drug, vaccine or medical device after it has been released on the market
Clinical ICSRs management
A complete life cycle management of clinical ICSRs safety reporting for better risk-benefit profiling of New Chemical Entities (NCEs)/Investigational New Drugs (INDs)
PADER Listings
An automated solution for pulling periodic adverse drug experience reports with predefined filters and logic to ensure accurate data output for US-FDA submissions
Medical Device Vigilance
An efficient and robust software module to register, track, maintain and analyze the complete events of device malfunction as well as the adverse events related to medical devices
Product Inquiry Trail and Response system (PrITR)
An efficient module to receive, process, evaluate, and record all the Product specific inquires, Medical information inquiries, and Product quality complaints (PQC) along with adverse events due to PQCs with regards to global compliance.
Signal Detection
A unique signal detection Software tool for Pharmacovigilance, combining advanced data mining algorithms with a qualitative review of each identified ICSR of interest, which is the current industry Gold standard.
Vaccine Vigilance
An automated safety solution designed for electronic reporting for vaccine products which offers both Vaccine safety recording and regulatory submissions
Pharmacovigilance Academic Module
Offers access to live pharmacovigilance application for those aspiring candidates who really want to make a difference with their presence in pharmcovigilance industry
Automated literature surveillance
An automated platform for all the end to end literature monitoring activities which covers wide range of medical and scientific journals in many languages from many countries