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Care without compromise: ensure vigilance through data

cubeSAFETY empowers pharmacovigilance teams with an automated, compliance-first system, offering thorough safety monitoring and enabling meticulous attention to detail.

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Submit with confidence, track with precision

Ensuring accurate reporting and regulatory compliance, cubeSAFETY simplifies case report submission and tracking.

Comprehensive safety management

Ensures regulatory compliance with ICH E2B and regional guidelines

Automatically translates entered data for CIOMS and XML submissions

Allows direct submission to FDA, EMA, CDE, MFDS, and PMDA using our dedicated gateways

Simplifies workflows with native AI features

Provides real-time submission tracking

Identifies safety signals from diverse data sources

Prevents and manages duplicate case entries

Offers easy access to agency feedback

Your ultimate safeguard for rigorous pharmacovigilance

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Experience CRScube

Simplify your workflow, boost productivity

AI-powered coding

Recommended medical coding terms and case narratives based on data input

Automated data entry

Import data from CIOMS PDF files with AI efficiency

Data transformation

Seamlessly import and export XML files and ICSR

Local & translated exports

Export raw or translated data as needed in multiple formats

cubeCDMS integration

Create cases with specific information, with bulk submission options

Transforming your safety management

Get peace of mind with cubeSAFETY and focus on what truly matters – maintaining safety and accuracy in your clinical trials.

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The CRScube difference

Developed by data managers

We understand your challenges because we've lived them

Continuous innovation

We're always pushing boundaries to serve you better

Loved by users

Our clients especially like the simple communication with regulatory agencies

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Innovation at work

Our success stories reveal how CRScube can transform your practice and clinical trial efficiency.

Featured case studies

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Reducing safety reporting budget by 80% with cubeSAFETY

A biotech company simplified their safety reporting, streamlined compliance and eliminated hidden fees.

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A leading korean pharma optimized PV operations with cubeSAFETY

This leading pharmaceutical company transformed its pharmacovigilance operations by integrating cubeSAFETY with cubeCDMS.

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See CRScube in action

Explore how our platform will elevate your team and clinical trial management.

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Care without compromise: ensure vigilance through data

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