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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 Drug Safety Triager?

Clarivate's Drug Safety Triager is a sophisticated pharmacovigilance solution designed to assist life sciences organizations in meeting regulatory requirements effectively. This tool, which has been validated for Good Practice (GxP) compliance and is ready for audit processes, optimizes the workflow involved in literature reviews, enabling pharmacovigilance experts to focus on patient safety by refining these actions. Fully aligned with the reporting requirements of leading global safety regulatory authorities such as the FDA and EMA, the Drug Safety Triager is accompanied by a thorough validation package with each implementation. The validation documentation is meticulously crafted to satisfy the rigorous standards established by the pharmaceutical industry and health governing bodies. Moreover, every literature item included undergoes a detailed review, ensuring that all user interactions are meticulously documented, thus creating a permanent, unalterable audit trail that promotes accountability and transparency. This forward-thinking approach not only boosts operational efficiency but also reinforces the unwavering dedication to upholding high standards in patient safety and compliance with regulations. Ultimately, the Drug Safety Triager represents a pivotal advancement for organizations striving to enhance their pharmacovigilance practices while ensuring robust safety and regulatory adherence.

Media

Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

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

Clarivate

Company Location

United Kingdom

Company Website

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

Categories and Features

Categories and Features

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