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Description
The IQVIA Vigilance Platform represents a holistic solution designed to streamline safety and pharmacovigilance tasks, enhancing speed, precision, and overall efficiency. Operating within a secure Software-as-a-Service (SaaS) environment and leveraging advanced proprietary technologies such as artificial intelligence, machine learning, and natural language processing, the Vigilance Platform provides valuable insights that enhance compliance, ensure product safety, and contribute significantly to the product development lifecycle. It comprehensively addresses every facet of pharmacovigilance, managing cases from initial patient reports through processing and submission to regulatory authorities, encompassing all types of cases. With its user-friendly interface, the IQVIA Vigilance Platform is accessible for affiliates, case processing teams, and those involved in signal detection. By adopting a transformative methodology in pharmacovigilance, it bolsters compliance, allowing organizations to concentrate on the rapid delivery of safer and more effective pharmaceuticals and medical devices. This innovative platform not only meets current industry needs but also anticipates future requirements in the evolving landscape of drug safety and efficacy.
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.
API Access
Has API
API Access
Has API
Integrations
Microsoft SharePoint
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€8,500 one-time payment
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
IQVIA
Country
United States
Website
www.iqvia.com/solutions/safety-regulatory-compliance/safety-and-pharmacovigilance/iqvia-vigilance-platform
Vendor Details
Company Name
K2C
Country
United Kingdom
Website
www.k2c.com/products/K2Pharma/PSMF.html