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Description
PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.
Description
Harnessing actionable insights from the leading AI-driven clinical analytics platform allows your teams to effectively manage risk and enhance performance throughout studies, systems, sites, and vendor relationships. The cutting-edge technology from Saama is specifically crafted to optimize workflows, automate labor-intensive tasks, and foster improved collaboration among various clinical functions such as operations, medical review, data management, biostatistics, and pharmacovigilance. Both sponsors and CROs depend on Saama's capabilities for data aggregation and AI solutions, which facilitate superior decision-making, minimize delays, and drastically reduce costs and timelines associated with drug development. By leveraging Saama's tools, you can accelerate the pace of clinical trial innovation. When your clinical data is centralized and continuously updated, it simplifies the lives of your ClinOps and medical review teams considerably. Furthermore, Data Managers, often undervalued, can shift their focus from repetitive tasks to the critical data points that truly drive project success, ensuring that their expertise is fully utilized in the process. This transformation not only enhances efficiency but also contributes to the overall quality of clinical outcomes.
API Access
Has API
API Access
Has API
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
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com
Vendor Details
Company Name
Saama
Founded
2011
Country
United States
Website
www.saama.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
Scientific Data Management System (SDMS)
Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows