Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • IQVIA Reviews & Ratings
    15 Ratings
    Company Website
  • RegDesk Reviews & Ratings
    13 Ratings
    Company Website
  • Polonious Reviews & Ratings
    2 Ratings
    Company Website
  • Yurbi Reviews & Ratings
    3 Ratings
    Company Website
  • D&B Risk Analytics Reviews & Ratings
    58 Ratings
    Company Website
  • FrameworkLTC Reviews & Ratings
    44 Ratings
    Company Website
  • JSCAPE MFT Server Reviews & Ratings
    179 Ratings
    Company Website
  • Doc Sheets Reviews & Ratings
    3 Ratings
    Company Website
  • Elation Health Reviews & Ratings
    72 Ratings
    Company Website
  • CodeSignal Reviews & Ratings
    920 Ratings
    Company Website

What is Oracle Argus?

Argus emerges as the leading and trustworthy solution for the effective management, analysis, and reporting of adverse event cases associated with both premarket and post-market pharmaceuticals, biologics, vaccines, devices, and combination products. By bolstering your case management functions, it incorporates advanced features such as integrated automation, streamlined workflows, and touchless processing options tailored to meet your specific requirements. This well-established solution guarantees adherence to global regulations and standards governing drugs, vaccines, and devices, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP, making it a reliable choice for organizations across the globe. Users of Argus Advanced Cloud benefit from Oracle Analytics, an AI-powered tool designed to unveil critical insights and facilitate prompt, informed decision-making. As teams responsible for medicinal product safety confront the difficulties of rising caseloads, varied signal detection data sources, and shifting regulations, they are often constrained by limited budgets and resources, highlighting the necessity for efficient solutions like Argus. Furthermore, this platform not only supports organizations in upholding safety and compliance in a multifaceted environment but also enhances their operational efficiency for ongoing success. In conclusion, Argus is indispensable for organizations striving to navigate the complexities of product safety while maximizing their resource utilization.

What is K2C PSMF Solution?

The K2C PSMF Solution introduces a groundbreaking approach to managing the Pharmacovigilance System Master File. It is crucial to periodically revise this document whenever significant changes occur in the pharmacovigilance protocols. These changes require input from multiple roles within the organization to modify a cohesive document that is structured according to regulatory guidelines. However, the process of coordinating these edits can be quite difficult, particularly because certain sections must be limited to designated editors and kept hidden from other contributors. To tackle this issue, the K2C solution treats each paragraph and annex as individual documents, making it easier to compile the final PSMF document by combining these various components. Furthermore, the K2C PSMF Solution manages contributions to the PSMF as separate entities, allowing for the control of access rights for both viewing and editing, while also providing thorough oversight of the entire document lifecycle, thereby ensuring compliance and efficiency throughout the entire process. This organized method not only improves collaboration among teams but also reinforces adherence to regulatory standards, ultimately enhancing the overall quality of the pharmacovigilance practices within the organization. As a result, the K2C PSMF Solution is an essential tool for organizations aiming to streamline their pharmacovigilance efforts.

Media

Media

Integrations Supported

AccelSafety
Compier Literature Screening
Microsoft SharePoint
Oracle Analytics Cloud

Integrations Supported

AccelSafety
Compier Literature Screening
Microsoft SharePoint
Oracle Analytics Cloud

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

€8,500 one-time payment
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Oracle

Date Founded

1977

Company Location

United States

Company Website

www.oracle.com/life-sciences/safety-solutions/argus-safety-case-management/

Company Facts

Organization Name

K2C

Company Location

United Kingdom

Company Website

www.k2c.com/products/K2Pharma/PSMF.html

Categories and Features

Categories and Features

Popular Alternatives

Popular Alternatives

TARA PV Reviews & Ratings

TARA PV

MedGenesis
SafetyEasy Reviews & Ratings

SafetyEasy

EXTEDO