Evidex

Evidex

Advera Health Analytics
PvEdge

PvEdge

Sarjen Systems
+
+

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About

Automated surveillance of any data source, fully integrated with a GVP IX compliant signal management platform. GVP-IX compliant signal management platform integrated within Evidex and ready to use off-the-shelf. Modernize and audit-proof your management processes without having to move back and forth between platforms and services. Unlock the value of your safety data. When you automate signal detection and management, you can focus not just on regulatory requirements, but on driving value for your organization. Identify safety signals from traditional sources like ICSR databases, FDA Adverse Event Reporting System (FAERS), VigiBase and clinical trial data. Include new data sources such as claims, EHR, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions.

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.

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

Pharmacovigilance software for pharmacies wanting to detect, manage, and mitigate drug safety issues

Audience

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

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

No information available.
Free Version
Free Trial

Reviews/Ratings

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

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Reviews/Ratings

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

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

Advera Health Analytics
Founded: 2010
United States
www.adverahealth.com

Company Information

Sarjen Systems
Founded: 1998
India
pvedge.sarjen.com

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Categories

Categories

Integrations

Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL

Integrations

Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL
Claim Evidex and update features and information
Claim Evidex and update features and information
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Claim PvEdge and update features and information