PvEdge

PvEdge

Sarjen Systems
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About

Document management and ensures regulatory compliance in clinical trials. By integrating AI and a unique "co-pilot" feature, our platform boosts efficiency while maintaining human oversight. Automated Filing with AI The AI assistant automates document classification and metadata assignment, reducing manual effort. Co-Pilot for Human Control The "co-pilot" feature allows users to set confidence levels for AI classification. Documents below the threshold are flagged for review, and users can adjust classifications, helping the AI improve. Key Benefits: Efficiency: AI automates tasks, allowing more focus on critical activities. Accuracy: AI and co-pilot oversight ensure data integrity and compliance. User-Friendly: An intuitive interface simplifies document management. Continuous Learning: AI improves accuracy with ongoing user feedback.

About

PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

CRO, Biopharma, Medical Devices

Audience

Pharmaceutical companies and healthcare organizations seeking solution to manage pharmacovigilance activities, ensuring compliance

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$1300.00
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 4.7 / 5
ease 5.0 / 5
features 4.7 / 5
design 4.7 / 5
support 5.0 / 5

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Pros & Cons from Real Users

Pros

  • The system has every feature that CRO may need. eTMF and EDC is implemented which saves money. Once Flex Databases is implemented you will no longer concern about regulatory issues.
  • CTMS was implemented really fast. Learning process is excellent. eTMF integrated - helps to save lot of money. The platform has it all.
  • Clinical Trial Management System, Document Management, Patient Management, Patient Monitoring, and Randomization are some of the features provided by Flex Database.

Cons

  • Wasn't so easy to understand everything through companies' website. Better book a call.
  • Nothing to complain about. The platform is operates excellently.
  • Quite costly, not available on Windows and Mac. Only available on the cloud as SaaS.

Pros & Cons from Real Users

Pros

  • User-Friendly Interface – Easy to navigate, even for mid- to large-sized teams. Responsive Support Team – Actively listens to feedback and implements improvements. AI-Powered Modules – Automation in case intake, triage, and literature screening reduces manual workload and improves efficiency. Frequent Version Upgrades – Keeps the system aligned with evolving regulatory requirements. Easy Integrations – Smooth connectivity with regulatory gateways, third-party tools, and internal systems. Cost-Effective – Offers enterprise-level capabilities at a competitive price compared to larger vendors.

Cons

  • Initial Learning Curve – Advanced AI and automation features may require some initial training. Customization Time – Specific workflow customizations may take time depending on requirements. Dependence on Upgrades – Frequent updates require teams to stay aligned with new feature releases.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Flex Databases
Founded: 2011
Czech Republic
www.flexdatabases.com/en/

Company Information

Sarjen Systems
Founded: 1998
India
pvedge.sarjen.com

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Dialog

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Trimble CoPilot

Trimble CoPilot

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TypeAce

TypeAce

Toh Kar Le
Co-Pilot

Co-Pilot

FIX Flyer

Categories

Categories

Clinical Trial Management Features

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 Features

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

Integrations

MainEDC

Integrations

MainEDC
Claim Flex Databases and update features and information
Claim Flex Databases and update features and information
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Claim PvEdge and update features and information