cubeSAFETYCRScube
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eProtocolKey Solutions
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Related Products
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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.
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About
eProtocol is a web-based research compliance platform for institutions that manage human-subjects, animal, biosafety, and other regulated research. It supports protocol development and electronic submission, committee review and approval workflows, amendments, renewals, adverse-event reporting, automated routing and reminders, version control, meeting agendas and minutes, audit trails, and reporting. Investigators, coordinators, reviewers, and compliance administrators can track protocol status and access records through a shared system. eProtocol includes modules for IRB, IACUC, IBC, stem-cell, chemical-safety, radiation-safety, controlled-substance, and post-approval monitoring workflows. It is designed for universities, research institutions, hospitals and academic medical centers, biotech and pharmaceutical organizations, and government research agencies.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management
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Audience
Research compliance offices, IRB/IACUC committees, investigators, vivarium teams and research administrators at universities, research institutions, hospitals, biotech, pharma and federal agencies.
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Support
Phone Support
Supported
24/7 Live Support
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Online
Supported
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Support
Phone Support
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24/7 Live Support
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Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
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Free Trial
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Pricing
No information available.
Free Version
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Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
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Live Online
Supported
In Person
Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationCRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety
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Company InformationKey Solutions
Founded: 1991
United States
www.keyusa.com
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Categories |
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Integrations
XML
Not Supported
cubeCDMS
Not Supported
cubeCTMS
Not Supported
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