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What is Quanticate?

Quanticate offers a broad range of pharmacovigilance services, which encompass the creation and management of safety databases tailored for this field. These databases serve as the main repository for individual case safety reports collected globally regarding a company's pharmaceutical offerings. It is essential to keep these databases up to date with the latest regulatory requirements and to ensure they meet international standards as well as business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, the types of hosting options available (including internal setups, third-party hosting, or cloud solutions from vendors), prior experiences, and compatibility with current systems. They caution that many commercial databases may claim compliance with standards like ISO ICSR ICH-E2B, but true adherence requires careful configuration, thorough validation, and consistent management. Moreover, continuous support and timely updates are vital for preserving the efficiency and dependability of these safety databases as they evolve. Therefore, the choice of database can significantly influence the overall success of pharmacovigilance efforts.

What is Evidex?

Efficiently monitoring a variety of data sources, in conjunction with a GVP IX compliant signal management system, can significantly enhance the way safety data is processed. The Evidex platform provides a comprehensive, ready-to-use solution that adheres to GVP-IX standards, allowing for smoother operations without the need to navigate through multiple services. By updating your management workflows, you can create processes that are both efficient and resistant to audits. This level of automation aids in fulfilling regulatory requirements while simultaneously increasing the overall benefits for your organization. Through the use of automated signal detection, safety signals can be recognized from key resources, such as ICSR databases and the FDA's Adverse Event Reporting System (FAERS), alongside VigiBase and clinical trial information. Additionally, you can enhance your data landscape by adding other sources like claims, electronic health records (EHR), and various forms of unstructured data. By combining these different data sources, you can enhance signaling algorithms, streamline validation processes, and respond more swiftly to urgent drug safety issues. Furthermore, this innovative approach redefines how organizations handle and utilize safety data, ultimately leading to improved results and a more proactive stance on drug safety management.

Media

Media

Integrations Supported

Integrations Supported

Amazon EC2
Amazon RDS
Amazon Web Services (AWS)
PostgreSQL

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Quanticate

Date Founded

1994

Company Location

United Kingdom

Company Website

www.quanticate.com/pharmacovigilance-safety-database

Company Facts

Organization Name

Advera Health Analytics

Date Founded

2010

Company Location

United States

Company Website

www.adverahealth.com

Categories and Features

Pharmacovigilance

Not specified

Categories and Features

Drug Discovery

Not specified

Pharmacovigilance

Not specified

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