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Description
PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.
Description
Biologit provides an extensive range of software and services aimed at improving safety surveillance in multiple sectors. Their leading offering, biologit MLM-AI, is a comprehensive medical literature monitoring system that utilizes AI technology for both global and local applications. This user-friendly, web-based platform is validated for compliance, resulting in enhanced efficiency for both human and veterinary pharmacovigilance. Notable features encompass integrated search capabilities and customizable literature screening processes, yielding productivity improvements of up to 70% thanks to AI support. Additionally, it presents a flexible and validated SaaS framework that meets GxP standards and adheres to CFR-11 regulations, alongside a database that consolidates significant global and local literature resources while ensuring automatic article de-duplication. Beyond their software offerings, Biologit also provides expert consultancy services related to pharmacovigilance and veterinary pharmacovigilance, further strengthening their commitment to safety in various fields. Their dedication to innovation and compliance positions them as a leader in the industry.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com
Vendor Details
Company Name
biologit
Founded
2021
Country
Ireland
Website
www.biologit.com