cubeSAFETY

cubeSAFETY

CRScube
+
+

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About

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content

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 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 Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Operational and regulatory teams looking for a toolkit to prepare complete and compliant submission ready documents and records

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 Supported
24/7 Live Support Not Supported
Online Supported

Support

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

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

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 Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Montrium
Canada
www.montrium.com

Company Information

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

Alternatives

Alternatives

SafetyEasy

SafetyEasy

AB Cube
LifeSphere RIMS

LifeSphere RIMS

ArisGlobal
KnowledgeNET

KnowledgeNET

Sarjen Systems
Thrana Safety Database

Thrana Safety Database

Thrana Softech
GlobalSubmit

GlobalSubmit

Certara
Clienvo eTMF

Clienvo eTMF

Clinevo

Categories

Categories

Pharmacovigilance Supported

Document Management Features

Access Controls Not Supported
Archiving & Retention Not Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Not Supported
Document Delivery Not Supported
Document Indexing Not Supported
Document Retention Supported
Electronic Signature Supported
Email Management Not Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Not Supported
Full Text Search Not Supported
Offline Access Not Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Integrations

Montrium Connect Supported
XML Not Supported
cubeCDMS Not Supported
cubeCTMS Not Supported

Integrations

Montrium Connect Not Supported
XML Supported
cubeCDMS Supported
cubeCTMS Supported
Claim RegDocs Connect and update features and information
Claim RegDocs Connect and update features and information
Claim cubeSAFETY and update features and information
Claim cubeSAFETY and update features and information