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Concise Signal Management Quality Database

White Papers

Home / Downloads / White Papers

Download here various white papers on Pharmacovigilance, Safety Database Software, Signal Management and More:

Concise Signal Management & Quality Database

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Pharmacovigilance Signal Monitoring: Perspective of MAH & Regulatory

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Designed by pharmacovigilance experts
Cost effective pharmacovigilance solution
Compliant with E2B, US FDA 21 CFR part 11 guidelines
Integrated MedDRA browser
Easy XML file import and export
Case validation based on in-built EMA business rules
Integrated workflow stages (customizable)
Auto narrative generation ensuring consistency across all cases

Sarjen's PvNET in nutshell

A single platform for serious adverse event (SAE) reporting for medicinal drugs, medical devices and drug therapies.
Global database which fulfills drug safety requirements of multiple regions, viz., Europe, Canada, USA, Australia, etc.
Dynamic homepage helps to meet regulatory compliance and maintain work allocation across different users.
Add-on functionalities for seamless ADR case processing.

What's New

Veterinary

Allows Initial/Follow-up Adverse event reporting of veterinary medicinal products
Allows generation of all standard reports like E2B XML, FDA 1932, CVMP
Integrated VeDDRA coded terminologies

E2B (R3)

New ICH guidelines for electronic submission of Individual Case Safety Report (ICSR) data elements and message specification
Sarjen's PvNET integrates these new E2B (R3) guidelines to generate XML's

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