Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • Qualio Reviews & Ratings
    4.4 out of 5 stars 919 Ratings
    Company Website for Qualio
  • ONLYOFFICE Docs Reviews & Ratings
    4.6 out of 5 stars 715 Ratings
    Company Website for ONLYOFFICE Docs
  • Vaiz Reviews & Ratings
    4.5 out of 5 stars 52 Ratings
    Company Website for Vaiz
  • TheBestPDF Reviews & Ratings
    4.3 out of 5 stars 40,303 Ratings
    Company Website for TheBestPDF
  • Adobe Acrobat Reviews & Ratings
    4.5 out of 5 stars 8,461 Ratings
    Company Website for Adobe Acrobat
  • PDF Guru Reviews & Ratings
    4.3 out of 5 stars 106,163 Ratings
    Company Website for PDF Guru
  • Apryse PDF SDK Reviews & Ratings
    4.2 out of 5 stars 172 Ratings
    Company Website for Apryse PDF SDK
  • MobiOffice Reviews & Ratings
    4.6 out of 5 stars 16,027 Ratings
    Company Website for MobiOffice
  • GroupTogether Reviews & Ratings
    4.6 out of 5 stars 4,887 Ratings
    Company Website for GroupTogether
  • MobiPDF Reviews & Ratings
    4.6 out of 5 stars 8,243 Ratings
    Company Website for MobiPDF

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 Fusion eClinical Suite?

Axiom has developed Fusion, a unique and affordable eClinical platform designed specifically for small to medium-sized companies in the device, pharmaceutical, and biotech sectors. This comprehensive eClinical Suite offers customizable Modules tailored to your study’s specific requirements. If you are conducting a smaller study, you can select a foundational setup that includes Electronic Data Capture (EDC) and Data Management (DM), along with Adverse Event (AE) and Serious Adverse Event (SAE) tracking. For those seeking enhanced functionalities, Fusion provides advanced Modules such as Inventory Tracking, Randomization and Trial Supply Management (RTSM), and Safety Management to streamline study oversight. The platform also facilitates the electronic collection of study data, even in offline scenarios, ensuring that once an internet connection is available, your information seamlessly syncs with the Fusion databases. This capability enables real-time access to records relevant to subject screening activities, while the Fusion Safety Database effectively supports the management of pharmacovigilance events for improved patient safety. Overall, Fusion stands out as a versatile solution to meet diverse clinical trial needs.

Media

Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

API Availability

API Availability

Pricing Information

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

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

K2C

Company Location

United Kingdom

Company Website

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

Company Facts

Organization Name

Axiom Real-Time Metrics

Company Website

www.axiommetrics.com

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
HIPAA Compliant
Monitoring
Patient Database
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

Pharmacovigilance

Not specified

Popular Alternatives

PvEdge Reviews & Ratings

PvEdge

Sarjen Systems
5.0 out of 5 stars

Popular Alternatives

TrialKit Reviews & Ratings

TrialKit

Crucial Data Solutions
AIFMD Annex IV Reporting Reviews & Ratings

AIFMD Annex IV Reporting

Matterhorn Reporting Services