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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 Clienvo eTMF?

Clinevo's electronic Trial Master File (eTMF) provides a streamlined digital platform for the organization and archiving of documents, images, and various digital assets pertinent to clinical trials. This eTMF is designed with an integrated DIA reference model and adheres to regulatory requirements. In addition to this, Clinevo features the MICC Intake, a web-based tool tailored for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) experts, enabling them to efficiently log, track, and manage Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Moreover, Clinevo Safety acts as a robust cloud-based system that simplifies the Pharmacovigilance process while ensuring compliance with regulations, covering PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals all within one unified platform. Additionally, the Clinevo Website Intake tool can be easily integrated with Sponsor or CRO websites, providing an intuitive web interface for consumers and reporters to access and submit reports effortlessly. This comprehensive range of tools not only streamlines clinical trial management but also significantly enhances safety reporting efficiency and effectiveness. Ultimately, Clinevo's innovative solutions are designed to meet the evolving needs of the clinical research landscape.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Free
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
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

OpenSourcePV

Date Founded

2019

Company Location

United States

Company Website

www.opensourcepv.com

Company Facts

Organization Name

Clinevo

Company Location

United States

Company Website

www.clinevotech.com

Categories and Features

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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