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Pharmacovigilance

cubeSAFETY

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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

Identifies safety signals from diverse data sources

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

Automatically translates entered data for CIOMS and XML submissions

Better processes

Provides real-time submission tracking

Prevents and manages duplicate case entries

Simplifies workflows with native AI features

Offers easy access to agency feedback

Simplify your workflow, amplify your impact

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Experience CRScube

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Your ultimate safeguard for rigorous pharmacovigilance

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AI-powered coding

Recommended medical coding terms and case narratives based on data input

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Automated data entry

Import data from CIOMS PDF files with AI efficiency

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Data transformation

Seamlessly import and export XML files and ICSR

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Local & translated exports

Export raw or translated data as needed in multiple formats

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cubeCDMS integration

Create cases with specific information, with bulk submission options

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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Improving the clinical data capture process with cubeDDC

The reliance on paper-based source documents and subsequent transcription into an Electronic Data Capture (EDC) system led to transcription errors, delayed data entry, and increased source data verification (SDV) costs.

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Efficiency by combining EDC and IRT

This European CRO’s decision to implement a combined approach with cubeCDMS and cubeIWRS provided them with an integrated, cost-effective, and innovative solution.

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Migrating to cubeCDMS to reduce costs and increase flexibility

This client leveraged cubeCDMS to reduce direct costs by an estimated 50-60% compared to their original EDC vendor.

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The cornerstone of clinical data innovation

See CRScube in action

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

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The cornerstone of clinical data innovation

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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