Average Ratings 0 Ratings
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
Envision having all your regulatory details related to products, registrations, submissions, correspondence, and commitments consolidated in a single, easily accessible location. With Ennov RIM, companies in the life sciences sector can enhance their regulatory workflows, elevate data integrity, swiftly address crucial business inquiries, and efficiently fulfill requests from health authorities. Specifically designed for the oversight and monitoring of therapeutic product information and registration data, Ennov RIM is rooted in Ennov Process. Regardless of whether you are preparing for the introduction of a new product or managing adjustments to current registrations, Ennov RIM equips regulatory teams with essential information and tools to proficiently oversee product portfolios on a global scale. This comprehensive approach not only fosters compliance but also promotes strategic decision-making across the organization.
API Access
Has API
No
API Access
Has API
No
Integrations
Ennov Regulatory Suite
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com/solutions/pharmacovigilance/
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com/regulatory-content-information-management/rim-regulatory-information-management/