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Description

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

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.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

AccelSafety
Compier Literature Screening
Microsoft SharePoint
Oracle Analytics Cloud

Integrations

AccelSafety
Compier Literature Screening
Microsoft SharePoint
Oracle Analytics Cloud

Pricing Details

€8,500 one-time payment
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

K2C

Country

United Kingdom

Website

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

Vendor Details

Company Name

Oracle

Founded

1977

Country

United States

Website

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

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Product Features

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