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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 Flex Databases?

Flex Databases offers a cutting-edge, integrated, and compliant electronic clinical platform that delivers software solutions tailored for clinical trials, serving pharmaceutical companies and contract research organizations (CROs). Our comprehensive system includes a Clinical Trial Management System, an Electronic Trial Master File, a project management and budgeting tool specifically crafted for the clinical trials sector, a Pharmacovigilance System, and a Learning Management System. This adaptable platform was developed through the expertise of a skilled team of over 100 professionals who possess extensive knowledge of the complexities involved in the clinical trial process. Additionally, our commitment to innovation ensures that we continually evolve our offerings to meet the changing needs of the industry.

Media

Media

Integrations Supported

MainEDC
Microsoft SharePoint

Integrations Supported

MainEDC
Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

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

Pricing Information

$1300.00
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

Flex Databases

Date Founded

2011

Company Location

Czech Republic

Company Website

www.flexdatabases.com/en/

Categories and Features

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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