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Description
NewTn's SAFETY is a cutting-edge cloud platform for pharmacovigilance that aims to streamline safety processes and ease compliance for pharmaceutical companies, emerging startups, and contract research organizations. This solution presents a wide array of features, such as scalable cloud infrastructure for enhanced data storage and processing, the ability to reuse data to avoid repetitive entries, real-time alerts and monitoring to swiftly detect adverse reactions, and strong reporting capabilities that aid in creating DSUR and PBRER reports. Specific use cases demonstrate its value in building pharmaceutical safety databases for new companies, offering budget-friendly safety solutions for cost-conscious CROs, improving regulatory adherence for small and medium-sized pharmaceutical firms, and providing thorough safety data analysis and reporting. The platform is distinguished by its user-friendly interface and experience, along with its specialized support for DSUR and PBRER reporting, making it a versatile and customized solution for various stakeholders in the pharmaceutical industry. Moreover, NewTn's SAFETY ensures that all users can effectively navigate the complexities of safety management with confidence and ease.
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.
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
NewTn-SAFETY
Country
United States
Website
safety.newtn.life/
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com