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Description

The Drug Safety Triager, developed by Clarivate, represents an advanced pharmacovigilance tool aimed at helping life sciences organizations adhere to regulatory standards. This system, which is validated for Good Practice (GxP) compliance and prepared for audits, enhances and organizes the workflow associated with literature reviews, allowing pharmacovigilance professionals to prioritize patient safety by streamlining these processes. Fully compliant with the reporting demands of major global safety regulatory bodies, including the FDA and EMA, the Drug Safety Triager includes a comprehensive validation package with every implementation. The validation documentation is carefully constructed to meet the stringent requirements set forth by the pharmaceutical sector and health authorities. Additionally, every piece of literature referenced is subjected to a meticulous review process that ensures all user actions are recorded, creating a permanent, immutable audit trail for accountability and transparency. This innovative approach not only improves efficiency but also reinforces the commitment to maintaining high standards in patient safety and regulatory compliance.

Description

OpenSourcePV, established by Lionel Van Holle in 2019, aims to leverage free and open-source technologies to enhance pharmacovigilance standards and offer a cost-effective alternative to costly specialized software in this field. Pharmaceutical companies are required to monitor the safety of their products to meet regulatory requirements, but as they expand their product lines and pipelines, the volume of data that needs to be analyzed quickly becomes overwhelming for manual review. Currently, they face a dilemma: invest in an expensive software suite or attempt to develop a solution in-house. OpenSourcePV supports these companies in their journey towards effective quantitative signal detection by providing access to pre-built modules while also enabling customization to fit their unique requirements and data sources. This flexibility allows them to efficiently handle large datasets and improve their overall pharmacovigilance processes.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

Free
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

Clarivate

Country

United Kingdom

Website

clarivate.com/life-sciences-healthcare/research-development/pharmacovigilance-drug-safety/drug-safety-triager/

Vendor Details

Company Name

OpenSourcePV

Founded

2019

Country

United States

Website

www.opensourcepv.com

Product Features

Product Features

Compier Literature Screening Reviews

Compier Literature Screening

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AccelSafety Reviews

AccelSafety

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