Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Streamlined surveillance of diverse data sources, seamlessly integrated with a GVP IX compliant signal management platform, can revolutionize your safety data handling. The Evidex platform offers a ready-to-go, GVP-IX compliant signal management solution that simplifies your operations without the hassle of switching between various services. By modernizing your management processes, you can ensure they are audit-proof and efficient. This automation not only helps meet regulatory standards but also enhances the overall value generated for your organization. With automated signal detection, you can identify safety signals from established sources such as ICSR databases, the FDA's Adverse Event Reporting System (FAERS), VigiBase, and clinical trial data. Furthermore, you can incorporate additional data sources, including claims, electronic health records (EHR), and other unstructured information. By aggregating these diverse data pools, you can significantly improve signaling algorithms, streamline validations and assessments, and accelerate responses to pressing drug safety inquiries. Ultimately, this approach transforms how organizations manage and leverage safety data for better outcomes.
Description
Quanticate delivers extensive services in pharmacovigilance, which include the establishment and oversight of safety databases specific to pharmacovigilance. These safety databases act as the primary collection point for individual case safety reports gathered worldwide for a company's pharmaceutical products. Keeping these databases current with the latest regulatory guidelines and ensuring they are validated according to international standards and business requirements is crucial. Quanticate underscores the necessity of choosing the appropriate database by evaluating factors such as the costs associated with implementation and maintenance, the availability of hosting models (including internal infrastructure, third-party hosting, or vendor cloud solutions), previous experiences, and how well they integrate with existing systems. They warn that, despite many commercial databases claiming adherence to standards like ISO ICSR ICH-E2B, achieving genuine compliance necessitates meticulous configuration, validation, and ongoing management. Furthermore, ongoing support and updates are critical to maintain the integrity and reliability of these safety databases over time.
API Access
Has API
No
API Access
Has API
No
Integrations
Amazon EC2
Yes
Amazon RDS
Yes
Amazon Web Services (AWS)
Yes
PostgreSQL
Yes
Integrations
Amazon EC2
No
Amazon RDS
No
Amazon Web Services (AWS)
No
PostgreSQL
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
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Advera Health Analytics
Founded
2010
Country
United States
Website
www.adverahealth.com
Vendor Details
Company Name
Quanticate
Founded
1994
Country
United Kingdom
Website
www.quanticate.com/pharmacovigilance-safety-database