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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 DrugCard?

DrugCard is an AI-powered pharmacovigilance platform designed to help pharmaceutical companies, CROs, and drug safety teams automate routine safety intelligence workflows, reduce manual screening, and maintain audit-ready pharmacovigilance processes. The platform supports global and local medical literature monitoring, regulatory intelligence, and adverse event data management in one connected workflow. DrugCard helps PV teams detect relevant safety information faster, review AI-generated article summaries, prioritize safety-relevant publications, translate local sources, create cases from literature, and maintain full traceability across screening and review activities. DrugCard’s literature monitoring solution covers 121+ countries, 2,200+ local medical sources, and 100+ languages, combining global sources such as PubMed with local, non-indexed journals that are often difficult to monitor manually. The system provides configurable projects, automated monitoring, keyword highlighting, AI pre-assessment of safety relevance, automated reports, notifications, QC workflows, audit trails, and documentation-ready outputs. In addition to literature monitoring, DrugCard includes AI-powered Regulatory Intelligence for tracking updates from health authorities and an Adverse Event Database for centralized safety data collection, E2B(R2/R3) support, reporting, analytics, and compliant case management. DrugCard is built for pharmacovigilance teams that need scalable, transparent, and compliant automation while keeping human experts in control of final medical and regulatory decisions.

Media

Media

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

individual
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

Sarjen Systems

Date Founded

1998

Company Location

India

Company Website

pvedge.sarjen.com

Company Facts

Organization Name

DrugCard

Date Founded

2021

Company Location

Estonia

Company Website

drug-card.io

Categories and Features

Categories and Features

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