Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Argus stands out as the premier and reliable solution for managing, analyzing, and reporting adverse event cases linked to both premarket and post-market drugs, biologics, vaccines, devices, and combination products. Enhance your case management capabilities with advanced features like integrated automation, optimized workflows, and touchless processing options that adapt to your needs. This mature solution ensures compliance with global drug, vaccine, and device regulations and standards, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP, making it a dependable choice for organizations worldwide. With Argus Advanced Cloud, users gain access to Oracle Analytics, an AI-driven tool that not only reveals valuable insights but also enables quicker, more informed decision-making. As medicinal product safety teams navigate the challenges of increased caseloads, diverse signal detection data sources, and evolving regulations, they must do so with limited budgets and resources, making efficient solutions like Argus essential for their success. Ultimately, Argus helps organizations maintain safety and compliance in a complex landscape while optimizing operational efficiency.
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
AccelSafety
Compier Literature Screening
Oracle Analytics Cloud
Integrations
AccelSafety
Compier Literature Screening
Oracle Analytics Cloud
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
Oracle
Founded
1977
Country
United States
Website
www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com