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Description
Data MATRIX offers a comprehensive SaaS solution specifically designed for clinical trials. Since its inception in 2009, the Data MATRIX team has specialized in the processing and analysis of clinical data, creating documents that comply with the standards set by the Russian Ministry of Health, FDA, and EMA. Our software streamlines clinical trial processes, allowing users to efficiently manage and track progress online. Before launching a project, we meticulously adjust and validate our software to ensure that every aspect is considered for optimal performance. With a proven track record of completing 180 projects for pharmaceutical companies, biotech firms, and CROs, our solutions have led 6 out of the top 10 Big Pharma companies to achieve a 15% reduction in R&D expenses. Our dedicated team members take pride in their involvement with professional organizations that connect clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers associated with EMWA and AMWA. By continually enhancing our offerings, we remain committed to driving innovation in the clinical research landscape.
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.
API Access
Has API
API Access
Has API
Integrations
DailyPay
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
Data MATRIX
Country
Russian Federation
Website
www.dm-matrix.com/en/
Vendor Details
Company Name
PvEdge
Founded
1998
Country
India
Website
pvedge.sarjen.com
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