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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.
Description
SafetyEasy by EXTEDO is a robust software solution for managing pharmacovigilance and multivigilance, aimed at simplifying the handling of safety cases and vigilance information. It adheres to a wide range of drug safety regulations such as E2B(R3) and HL7 eMDR, while facilitating the necessary creation of regulatory documents including PSUR, PBRER, and DSUR. The software is equipped with features that optimize workflows through email alerts and online dashboards, allowing users to efficiently monitor project progress and adhere to submission timelines. Additionally, SafetyEasy features sophisticated tools like CasEasy AI, which leverages Natural Language Processing to streamline the automation of case creation, alongside a Business Intelligence module that offers an insightful 360° perspective on scientific data, thereby improving case evaluation and safety signal identification. This cloud-based platform is not only quick to deploy but also designed for ease of use, requiring very little training for effective operation. Furthermore, the integration of these advanced functionalities makes SafetyEasy an invaluable asset for organizations aiming to enhance their pharmacovigilance processes.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
Free
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
OpenSourcePV
Founded
2019
Country
United States
Website
www.opensourcepv.com
Vendor Details
Company Name
EXTEDO
Founded
2003
Country
Germany
Website
www.extedo.com/software/pharmacovigilance-and-drug-safety