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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 Dialog?

Dialog presents a thorough and adaptable solution for monitoring pharmacovigilance literature, aimed at improving the operational effectiveness of drug safety reporting organizations by automating and streamlining the literature triage process. It offers access to a vast array of over 140 esteemed scientific and medical literature databases, such as MEDLINE, Embase, and Biosis, which helps standardize content from diverse sources, thus ensuring a uniform approach to precision searching, deduplication, and structured XML output. The DialogML engine harnesses cutting-edge artificial intelligence to rank search results according to their relevance to patient safety, discern essential safety concepts, and categorize references related to Individual Case Safety Reporting (ICSRs), aggregated reports like PBRER, PSUR, and DSUR, as well as safety signals, allowing reviewers to quickly identify high-priority articles. Additionally, the Dialog Alerts Manager streamlines the alert creation and management process through features such as bulk editing capabilities, thorough audit trails for modifications in search strategies, customizable scheduling, and meticulous tracking of delivery histories. This cohesive system not only dramatically minimizes the time and effort needed for efficient literature monitoring but also empowers organizations to direct their attention toward more pressing drug safety concerns and enhance their overall reporting accuracy. Ultimately, this leads to improved patient safety outcomes and more effective regulatory compliance.

Media

Media

Integrations Supported

Microsoft SharePoint
XML

Integrations Supported

Microsoft SharePoint
XML

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

Clarivate

Company Location

United Kingdom

Company Website

clarivate.com/life-sciences-healthcare/research-development/pharmacovigilance-drug-safety/dialog/

Categories and Features

Categories and Features

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