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PvEdge, an efficient and compliant safety solution

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.

Presence

Since

 
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Hosting

Cloud ready solution

Compliance

Globally compliant

Audit & Inspections
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at client sites

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Indirect

 
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Users
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Cases Processed
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Validated Solution

Quick Implementation

Faster ROI

Data Migration

Solutions

  • PvEdge – Safety Database
    PvEdge – Safety Database

    PvEdge safety database provides comprehensive recording and analyses of adverse events arising from the use of different types of pharmaceutical products (Drug, Medical Device and Vaccine).

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  • PvEdge – Multisource Inbox And Triage
    PvEdge – Multisource Inbox And Triage

    An automated tool to deal with the cases/information received from multiple sources such as client's source documents (structured & unstructured), e-mails, fax, literature articles, and regulatory XMLs

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  • PvEdge – Control Document Management System
    PvEdge – Control Document Management System

    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.

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  • PvEdge - Quality Management System
    PvEdge - Quality Management System

    Sarjen’s PV Enterprise Quality management system enables implementation of quality processes like Deviations, CAPA, Change controls and Risk assessment for Pharmacovigilance and drug safety departments of CROs and Pharmaceuticals companies

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  • PvEdge - Gateway Connect
    PvEdge - Gateway Connect

    “Global ICSR submissions” is one of the integral aspects and most critical activity of every PV operations whether is MAH or PV service provider. A dedicated submissions team is assigned for this critical task of regulatory & partner ICSR submission.

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  • PvEdge - Academic Training
    PvEdge - Academic Training

    Offers access to live pharmacovigilance application for those aspiring candidates who really want to make a difference with their presence in pharmcovigilance industry

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  • PvEdge – Veterinary Vigilance
    PvEdge – Veterinary Vigilance

    A comprehensive veterinary safety reporting system that is compliant with the CVMP and VICH specifications

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