cubeSAFETY

cubeSAFETY

CRScube
eProtocol

eProtocol

Key Solutions
+
+

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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.

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.

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

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

Audience

Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management

Audience

Research compliance offices, IRB/IACUC committees, investigators, vivarium teams and research administrators at universities, research institutions, hospitals, biotech, pharma and federal agencies.

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Company Information

CRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety

Company Information

Key Solutions
Founded: 1991
United States
www.keyusa.com

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Categories

Pharmacovigilance Supported

Categories

Integrations

XML Supported
cubeCDMS Supported
cubeCTMS Supported

Integrations

XML Not Supported
cubeCDMS Not Supported
cubeCTMS Not Supported
Claim cubeSAFETY and update features and information
Claim cubeSAFETY and update features and information
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Claim eProtocol and update features and information