Audience

Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products

About Quanticate

Quanticate offers comprehensive pharmacovigilance services, including the provision and management of pharmacovigilance safety databases. A pharmacovigilance safety database serves as the central repository for individual case safety reports collected globally for a company's medicinal products. It is essential that these databases are up-to-date with the latest regulatory requirements and validated to meet international standards and business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, hosting model availability (internal infrastructure, third-party hosting, or vendor cloud options), prior experiences, and compatibility with other systems. They caution that while many commercially available databases claim compliance with standards like ISO ICSR ICH-E2B, true compliance requires careful setup, validation, and management.

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Company Information

Quanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database

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Product Details

Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
In Person
Videos
Support
Phone Support
Online

Quanticate Frequently Asked Questions

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