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features
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support

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Description

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

Description

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

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

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Axiom Real-Time Metrics

Website

www.axiommetrics.com

Vendor Details

Company Name

K2C

Country

United Kingdom

Website

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

Product 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

Product Features

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