PvEdge

PvEdge

Sarjen Systems
SafetyEasy

SafetyEasy

AB Cube
+
+

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About

PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.

About

Efficient drug safety operations with the technological expertise of industry veterans begins here. Align international pharmacovigilance operations teams with an intuitive, unified, cloud-based safety system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes. Growing biotechnology firms trust individual vigilances provided by AB Cube for their safety regulatory processes. Life sciences organisations manage adverse event reporting and stay compliant with the latest regulations with SafetyEasy® Suite. SafetyEasy® Suite is AB Cube’s all-in-one ecosystem for automated multivigilance management. Built to make safety simple, scalable, and smart. Designed for organizations of all sizes, it’s a modular, cloud-based platform that automates every step of the vigilance process, from early stage data capture to regulatory reporting and advanced analytics. Flexible and compliant by design,

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Pharmaceutical companies and healthcare organizations seeking solution to manage pharmacovigilance activities, ensuring compliance

Audience

Life sciences organizations wanting a solution to manage increasing volumes of safety cases and regulatory requirements in pharmacovigilance and related fields

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

Built for All Sizes and Needs
Only Pay for What You Pick. No Hidden Fees
Free Version
Free Trial

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Pros & Cons from Real Users

Pros

  • User-Friendly Interface – Easy to navigate, even for mid- to large-sized teams. Responsive Support Team – Actively listens to feedback and implements improvements. AI-Powered Modules – Automation in case intake, triage, and literature screening reduces manual workload and improves efficiency. Frequent Version Upgrades – Keeps the system aligned with evolving regulatory requirements. Easy Integrations – Smooth connectivity with regulatory gateways, third-party tools, and internal systems. Cost-Effective – Offers enterprise-level capabilities at a competitive price compared to larger vendors.

Cons

  • Initial Learning Curve – Advanced AI and automation features may require some initial training. Customization Time – Specific workflow customizations may take time depending on requirements. Dependence on Upgrades – Frequent updates require teams to stay aligned with new feature releases.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Sarjen Systems
Founded: 1998
India
pvedge.sarjen.com

Company Information

AB Cube
Founded: 2006
France
www.ab-cube.com/vigilance/

Alternatives

Dialog

Dialog

Clarivate

Alternatives

cubeSAFETY

cubeSAFETY

CRScube

Categories

Categories

Integrations

EDC Made Easy

Integrations

EDC Made Easy
Claim PvEdge and update features and information
Claim PvEdge and update features and information
Claim SafetyEasy and update features and information
Claim SafetyEasy and update features and information