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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.

What is DF Literature Monitor?

DF Literature Monitor is an innovative AI-powered platform designed to simplify the extensive task of literature monitoring and improve safety oversight protocols. It interfaces with essential local and global literature databases to gather articles simultaneously, employing advanced semantic search technology to effectively identify relevant research. The tool features automatic de-duplication, essential safety information extraction, and the ability to pre-fill safety case forms, which can be submitted to safety databases in E2B or Excel/PDF formats with just a single click. Additionally, it offers automated translation services for both abstracts and full articles into English, enhancing accessibility for diverse teams. DF Literature Monitor also boasts customizable workflows that foster collaboration and ensure rigorous quality control among pharmacovigilance professionals. By implementing this solution, organizations can potentially cut down on the time and resources dedicated to literature monitoring by 60% or more, all while upholding strict quality standards and regulatory compliance. This tool is a groundbreaking advancement in pharmacovigilance, enabling teams to concentrate on critical evaluation instead of tedious manual tasks, ultimately improving overall efficiency and effectiveness in safety monitoring.

Media

Media

Integrations Supported

DF mSafety AI
Microsoft Excel
Microsoft SharePoint

Integrations Supported

DF mSafety AI
Microsoft Excel
Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

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

Pricing Information

Pricing not provided.
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

K2C

Company Location

United Kingdom

Company Website

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

Company Facts

Organization Name

Datafoundry

Date Founded

2016

Company Location

India

Company Website

datafoundry.ai/literature-monitor/

Categories and Features

Categories and Features

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