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Average Ratings 0 Ratings

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ease
features
design
support

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Description

Ennov's Pharmacovigilance Suite serves as a comprehensive solution for the collection, management, assessment, and reporting of adverse events in both human and veterinary fields, all within a single database framework. It boasts sophisticated tools for signal detection and data analysis, reinforcing adherence to international regulatory standards. Notable features encompass streamlined case intake and triage processes, enhanced user interfaces for data entry, adaptable case input forms, and an extensive range of searchable vocabulary lists. The system accommodates various reporting formats, including both paper and electronic submissions, compatible with CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). In terms of signal detection and management, it offers extensive data querying options, robust analytical tools, and the ability to compute essential statistical measures such as PRR, ROR, and MGPS. Entirely web-based and user-friendly, the platform is built to meet the standards of 21 CFR Part 11, thereby guaranteeing the integrity and security of data. Moreover, its adaptability makes it suitable for organizations of all sizes, ensuring that users can efficiently navigate the complexities of pharmacovigilance.

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.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

Ennov

Founded

1999

Country

France

Website

en.ennov.com/solutions/pharmacovigilance/

Vendor Details

Company Name

Axiom Real-Time Metrics

Website

www.axiommetrics.com

Product Features

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

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