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
Tepsivo offers innovative pharmacovigilance software solutions that enhance the efficiency of drug safety processes through automation and intelligent templates, leading to a significant decrease in administrative workload and related expenses. The Tepsivo Platform is an all-encompassing, cloud-based system that empowers users to oversee all aspects of pharmacovigilance from a single, unified interface. Its notable features encompass a Quality Management System, oversight by a Local Contact Person for Pharmacovigilance (LCPPV), efficient safety reporting and follow-up mechanisms, PSUR tracking, management of signal detection, automated audit trails, compliance monitoring, tools for adverse event intake, literature surveillance, tracking of risk management systems, solutions for managing PSMF, automated reconciliation with partners, and CAPA management. By integrating these modules, the platform guarantees complete transparency, full compliance with regulations, preparedness for inspections, high-quality outputs, rapid processing times, elimination of administrative overhead, and reduced costs. With Tepsivo's solutions, organizations can enhance their pharmacovigilance capabilities while ensuring that they meet industry standards efficiently and effectively.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
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)
Yes
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)
Yes
In Person
Yes
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com/solutions/pharmacovigilance/
Vendor Details
Company Name
Tepsivo
Country
Finland
Website
www.tepsivo.com/pharmacovigilance-software/