Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
AccelSafety
No
Compier Literature Screening
No
Microsoft SharePoint
Yes
Oracle Analytics Cloud
No
Integrations
AccelSafety
Yes
Compier Literature Screening
Yes
Microsoft SharePoint
No
Oracle Analytics Cloud
Yes
Pricing Details
€8,500 one-time payment
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
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/