PvEdgeSarjen Systems
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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.
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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.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Pharmaceutical companies and healthcare organizations seeking solution to manage pharmacovigilance activities, ensuring compliance
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Audience
Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationSarjen Systems
Founded: 1998
India
pvedge.sarjen.com
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Company InformationQuanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database
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Integrations
No info available.
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Integrations
No info available.
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