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

Tepsivo's pharmacovigilance software solutions are designed to streamline drug safety processes through automation and smart templates, significantly reducing administrative burdens and associated costs. The Tepsivo Platform is a comprehensive, cloud-based application that allows users to manage all pharmacovigilance activities in one centralized location. Key features include a Quality Management System, Local Contact Person for Pharmacovigilance (LCPPV) oversight, streamlined safety reporting and follow-up tools, PSUR tracking, signal management tracking, automated audit trails, compliance tracking, adverse event intake tools, literature monitoring, risk management system tracking, PSMF management solutions, automated partner reconciliation, and CAPA management. These integrated modules ensure full transparency, 100% compliance, inspection readiness, high quality, rapid speed, no administrative overhead, and minimal cost.

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 regulatory professionals needing a solution to manage drug safety processes, 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 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

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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

Tepsivo
Finland
www.tepsivo.com/pharmacovigilance-software/

Alternatives

Dialog

Dialog

Clarivate

Alternatives

PvEdge

PvEdge

Sarjen Systems

Categories

Categories

Integrations

No info available.

Integrations

No info available.
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