cubeSAFETYCRScube
|
||||||
Related Products
|
||||||
About
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.
|
About
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.
|
|||||
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
|
|||||
Audience
Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products
|
Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
|
|||||
Support
Phone Support
24/7 Live Support
Online
|
Support
Phone Support
24/7 Live Support
Online
|
|||||
API
Offers API
|
API
Offers API
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
No information available.
Free Version
Free Trial
|
Pricing
No information available.
Free Version
Free Trial
|
|||||
Reviews/
|
Reviews/
|
|||||
Training
Documentation
Webinars
Live Online
In Person
|
Training
Documentation
Webinars
Live Online
In Person
|
|||||
Company InformationQuanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database
|
Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
|
|||||
Alternatives |
Alternatives |
|||||
|
|
|
|||||
|
|
|
|||||
|
|
||||||
Categories |
Categories |
|||||
Integrations
XML
cubeCDMS
cubeCTMS
|
||||||
|
|
|