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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
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