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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 Drug Safety Triager?

Clarivate's Drug Safety Triager is a sophisticated pharmacovigilance solution designed to assist life sciences organizations in meeting regulatory requirements effectively. This tool, which has been validated for Good Practice (GxP) compliance and is ready for audit processes, optimizes the workflow involved in literature reviews, enabling pharmacovigilance experts to focus on patient safety by refining these actions. Fully aligned with the reporting requirements of leading global safety regulatory authorities such as the FDA and EMA, the Drug Safety Triager is accompanied by a thorough validation package with each implementation. The validation documentation is meticulously crafted to satisfy the rigorous standards established by the pharmaceutical industry and health governing bodies. Moreover, every literature item included undergoes a detailed review, ensuring that all user interactions are meticulously documented, thus creating a permanent, unalterable audit trail that promotes accountability and transparency. This forward-thinking approach not only boosts operational efficiency but also reinforces the unwavering dedication to upholding high standards in patient safety and compliance with regulations. Ultimately, the Drug Safety Triager represents a pivotal advancement for organizations striving to enhance their pharmacovigilance practices while ensuring robust safety and regulatory adherence.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Quanticate

Date Founded

1994

Company Location

United Kingdom

Company Website

www.quanticate.com/pharmacovigilance-safety-database

Company Facts

Organization Name

Clarivate

Company Location

United Kingdom

Company Website

clarivate.com/life-sciences-healthcare/research-development/pharmacovigilance-drug-safety/drug-safety-triager/

Categories and Features

Categories and Features

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