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What is OpenSourcePV?

Founded by Lionel Van Holle in 2019, OpenSourcePV is dedicated to utilizing open-source technologies to improve standards in pharmacovigilance and provide a budget-friendly alternative to expensive specialized software. As pharmaceutical companies are obligated to ensure the safety of their products to comply with regulations, the increasing complexity of their product lines leads to an overwhelming amount of data that manual analysis struggles to manage. Currently, they are caught between the choice of investing in costly software solutions or attempting to create an internal system from scratch. OpenSourcePV aids these organizations on their path to effective quantitative signal detection by offering pre-built modules that can also be customized to meet specific needs and integrate with diverse data sources. This adaptability not only streamlines the management of extensive datasets but also enhances the overall efficiency of their pharmacovigilance efforts, paving the way for safer pharmaceuticals. As the industry evolves, the role of OpenSourcePV becomes increasingly crucial in supporting these companies to navigate their challenges.

What is Evidex?

Efficiently monitoring a variety of data sources, in conjunction with a GVP IX compliant signal management system, can significantly enhance the way safety data is processed. The Evidex platform provides a comprehensive, ready-to-use solution that adheres to GVP-IX standards, allowing for smoother operations without the need to navigate through multiple services. By updating your management workflows, you can create processes that are both efficient and resistant to audits. This level of automation aids in fulfilling regulatory requirements while simultaneously increasing the overall benefits for your organization. Through the use of automated signal detection, safety signals can be recognized from key resources, such as ICSR databases and the FDA's Adverse Event Reporting System (FAERS), alongside VigiBase and clinical trial information. Additionally, you can enhance your data landscape by adding other sources like claims, electronic health records (EHR), and various forms of unstructured data. By combining these different data sources, you can enhance signaling algorithms, streamline validation processes, and respond more swiftly to urgent drug safety issues. Furthermore, this innovative approach redefines how organizations handle and utilize safety data, ultimately leading to improved results and a more proactive stance on drug safety management.

Media

Media

Integrations Supported

Integrations Supported

Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL

API Availability

API Availability

Pricing Information

Free
Free Version

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Not specified

Company Facts

Organization Name

OpenSourcePV

Date Founded

2019

Company Location

United States

Company Website

www.opensourcepv.com

Company Facts

Organization Name

Advera Health Analytics

Date Founded

2010

Company Location

United States

Company Website

www.adverahealth.com

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

Drug Discovery

Not specified

Pharmacovigilance

Not specified

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