End-to-End Pharmacovigilance and Drug Safety Software
About PvEdge
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 Software 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.
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 Drug 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.
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End-to-End Pharmacovigilance and Drug Safety Software
OUR SOLUTIONS 01 02 03 Drug Safety Database Pharmacovigila nce Software Drug Safety Software End-to-End Pharmacovigilance and Drug Safety Software For more info: WEBSITE | BLOG
Drug Safety Database
PvEdge drug safety database is a robust system that offers extensive documentation and analysis of adverse events resulting from the utilization of various pharmaceutical products, including drugs, medical devices, and vaccines.
PvEdge stands out as an advanced and highly automated Pharmacovigilance solution, simplifying the management of safety data while addressing all risk management needs on a unified platform. This comprehensive approach guarantees compliance with global regulatory standards.
PvEdge offers following modules which are tightly integrated with each other to provide robust and efficient pharmacovigilance solution
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End-to-End Pharmacovigilance and Drug Safety Software
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OUR SOLUTIONS
● PvEdge – Drug Safety Database
○ Post Marketing Safety (PMS) Reporting
○ Clinical ICSR
○ Medical Device Vigilance
○ Vaccine Vigilance
○ Case Routing Workflow
○ Oversight and Operational Efficiency
○ MedDRA auto-update
○ Periodic Listings and PADERs
○ Signal Detection
● PvEdge – Multisource Inbox And Triage
○ PvD’Code – Structured Intake From Partners
○ PrITR – Unstructured Intake for PQC, MI and AE
○ LAM – Literature Intake Automation
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End-to-End Pharmacovigilance and Drug Safety Software
OUR SOLUTIONS
● PvEdge – Control Document Management System
○ Document Control
○ Report Compilation Automation
○ eCTD Publishing (PADER/PSUR)
○ Safety Data Exchange Agreement (SDEA)
● PvEdge - Quality Management System
○ Quality Processes
○ Training Records
● PvEdge - Gateway Connect ● PvEdge - Academic Training
● PvEdge – Veterinary Vigilance
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End-to-End Pharmacovigilance and Drug Safety Software
Address : 6th Floor, Arista, Anandnagar road, Ahmedabad 380015, India
Call Now - +91-79-66214899
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End-to-End Pharmacovigilance and Drug Safety Software
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End-to-End Pharmacovigilance and Drug Safety Software
10 THANKS! DO YOU HAVE ANY QUESTIONS? Your sarjen@sarjen.com +91 -79-66214899 https://pvedge.sarjen.com/ For more info: WEBSITE | BLOG End-to-End Pharmacovigilance and Drug Safety Software