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Description

Ennov's Pharmacovigilance Suite serves as a comprehensive solution for the collection, management, assessment, and reporting of adverse events in both human and veterinary fields, all within a single database framework. It boasts sophisticated tools for signal detection and data analysis, reinforcing adherence to international regulatory standards. Notable features encompass streamlined case intake and triage processes, enhanced user interfaces for data entry, adaptable case input forms, and an extensive range of searchable vocabulary lists. The system accommodates various reporting formats, including both paper and electronic submissions, compatible with CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). In terms of signal detection and management, it offers extensive data querying options, robust analytical tools, and the ability to compute essential statistical measures such as PRR, ROR, and MGPS. Entirely web-based and user-friendly, the platform is built to meet the standards of 21 CFR Part 11, thereby guaranteeing the integrity and security of data. Moreover, its adaptability makes it suitable for organizations of all sizes, ensuring that users can efficiently navigate the complexities of pharmacovigilance.

Description

Biologit provides an extensive range of software and services aimed at improving safety surveillance in multiple sectors. Their leading offering, biologit MLM-AI, is a comprehensive medical literature monitoring system that utilizes AI technology for both global and local applications. This user-friendly, web-based platform is validated for compliance, resulting in enhanced efficiency for both human and veterinary pharmacovigilance. Notable features encompass integrated search capabilities and customizable literature screening processes, yielding productivity improvements of up to 70% thanks to AI support. Additionally, it presents a flexible and validated SaaS framework that meets GxP standards and adheres to CFR-11 regulations, alongside a database that consolidates significant global and local literature resources while ensuring automatic article de-duplication. Beyond their software offerings, Biologit also provides expert consultancy services related to pharmacovigilance and veterinary pharmacovigilance, further strengthening their commitment to safety in various fields. Their dedication to innovation and compliance positions them as a leader in the industry.

API Access

Has API

API Access

Has API

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Screenshots View All

Integrations

No details available.

Integrations

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Pricing Details

No price information available.
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

Ennov

Founded

1999

Country

France

Website

en.ennov.com/solutions/pharmacovigilance/

Vendor Details

Company Name

biologit

Founded

2021

Country

Ireland

Website

www.biologit.com

Product Features

Product Features

Alternatives

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