PvEdge

PvEdge

Sarjen Systems
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+

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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

Quanticate offers comprehensive pharmacovigilance services, including the provision and management of pharmacovigilance safety databases. A pharmacovigilance safety database serves as the central repository for individual case safety reports collected globally for a company's medicinal products. It is essential that these databases are up-to-date with the latest regulatory requirements and validated to meet international standards and business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, hosting model availability (internal infrastructure, third-party hosting, or vendor cloud options), prior experiences, and compatibility with other systems. They caution that while many commercially available databases claim compliance with standards like ISO ICSR ICH-E2B, true compliance requires careful setup, validation, and management.

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

Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products

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 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

Quanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database

Alternatives

Dialog

Dialog

Clarivate

Alternatives

PvEdge

PvEdge

Sarjen Systems
Compier Literature Screening

Compier Literature Screening

Techsol Life Sciences

Categories

Categories

Integrations

No info available.

Integrations

No info available.
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