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Ratings and Reviews 0 Ratings
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What is PvEdge?
PvEdge represents a cutting-edge cloud-based software solution specifically designed for pharmacovigilance, offering thorough and compliant safety measures for pharmaceuticals, medical devices, vaccines, and their combinations. This innovative platform integrates a comprehensive safety database that simplifies the management of pharmacovigilance intake, case processing, submissions, AI-enhanced analytics, and safety signal detection, all within an intuitive interface. It is meticulously crafted to comply with both current and future regulatory requirements, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring adherence to global standards. By leveraging advanced automation powered by AI and machine learning, PvEdge greatly enhances the efficiency of managing drug safety databases. Key features include automated literature reviews, rapid ICSR submissions, intelligent triage processes, automated signal detection, and efficient document automation. Moreover, the platform incorporates a controlled document management system that aids in the creation, management, and distribution of vital pharmacovigilance documentation, coupled with a risk-based enterprise quality management framework that promotes strong quality control practices and keeps detailed training records. Overall, these multifaceted capabilities position PvEdge as an essential asset for organizations dedicated to maintaining exemplary standards in drug safety while adapting to the evolving landscape of regulatory demands. As a result, it empowers businesses to operate more effectively and responsibly in their commitment to patient safety.
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.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
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
PvEdge
Date Founded
1998
Company Location
India
Company Website
pvedge.sarjen.com
Company Facts
Organization Name
Axiom Real-Time Metrics
Company Website
www.axiommetrics.com
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