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Average Ratings 0 Ratings
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
Orbit is a comprehensive platform geared towards improving patient safety by aiding biopharma companies of all sizes in expanding their safety operations across international markets. This platform provides cutting-edge solutions for global pharmacovigilance, safety management, and risk oversight, with the goal of enhancing overall quality, ensuring compliance, boosting productivity and efficiency, and offering significant oversight of processes that are often complex and compartmentalized. Among its essential features are risk management and minimization, which facilitate the monitoring of commitments within global risk management plans while also supporting the implementation of local risk mitigation measures; management of safety data exchange and pharmacovigilance agreements, which enables effective oversight of global collaborations; as well as signal and surveillance management, which encompasses everything from strategy planning to detection activities, signal evaluation, and ongoing tracking. Additionally, Orbit’s user-friendly interface ensures that teams can easily navigate the platform and utilize its features to their fullest potential.
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
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
Orbit
Founded
2012
Country
United States
Website
www.workinorbit.com