cubeSAFETY by CRScube: Smarter pharmacovigilance and safety reporting
cubeSAFETY from CRScube is a pharmacovigilance and safety case reporting system that helps teams manage adverse event cases, regulatory submissions, and safety oversight with clarity and control. By supporting case intake, validation, medical coding, duplicate checks, signal detection, and direct agency submissions in one environment, cubeSAFETY helps pharmacovigilance teams reduce manual effort while maintaining the traceability expected in regulated safety operations.
Regulatory-compliant Case Reporting
cubeSAFETY complies with ICH E2B(R3) reporting and regional submission requirements, giving pharmacovigilance teams a structured way to prepare safety reports for global regulatory authorities.
Direct Gateway Submissions
With cubeSAFETY’s built-in agency gateways, teams submit safety reports directly to agencies including the FDA, EMA, CDE, MFDS, and PMDA, with submission tracking and access to agency feedback.
Real-Time Tracking & Validation
Built-in validation, duplicate controls, and submission status tracking help teams identify issues early and maintain clear oversight of case progress.
Proactive Signal Detection
cubeSAFETY includes signal detection capabilities that help teams identify, prioritize, and review potential safety trends using case data.
Connected Clinical Data
cubeSAFETY works alongside cubeCDMS and iMednet to support a unified flow of adverse event data from study capture to safety reporting.
See it in action
Read the CRScube case study on how on how a global pharma company accelerated safety system adoption with cubeSAFETY.
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How does cubeSAFETY support ICH E2B(R3) reporting?
cubeSAFETY supports structured ICSR reporting in line with ICH E2B(R3) requirements and regional regulatory rules. This helps pharmacovigilance teams prepare, validate, and submit safety reports in the formats required by global authorities.
Which regulatory agencies can cubeSAFETY submit to?
cubeSAFETY includes direct gateway submissions to major regulatory agencies: FDA, EMA, CDE, MFDS, and PMDA. Teams can also track submission status, acknowledgments, and agency feedback in the system.
How does cubeSAFETY help reduce manual case processing work?
cubeSAFETY supports AI-assisted medical coding, duplicate detection, automated data entry from supported sources, and validation checks during case processing. This helps reduce repetitive manual steps and supports more consistent case handling.
Can cubeSAFETY help identify potential safety sigals?
Yes. cubeSAFETY includes signal detection capabilities that help teams review case data, identify emerging safety trends, and prioritize follow-up on potential safety concerns.
How does cubeSAFETY improve data quality during safety reporting?
cubeSAFETY uses validation controls, duplicate checks, audit trails, and structured workflows to flag incomplete or inconsistent case data earlier in the process. This results in cleaner submissions and more reliable safety oversight.
Does cubeSAFETY work with clinical data capture systems?
Yes. cubeSAFETY works alongside cubeCDMS and iMednet, allowing adverse event data to move from clinical capture into safety reporting workflows with less duplicate entry.
Who is cubeSAFETY designed for?
cubeSAFETY is designed for sponsor and CRO pharmacovigilance teams that need a controlled way to manage adverse event cases, regulatory submissions, signal detection, and safety reporting across clinical trial and post-marketing workflows.
How does cubeSAFETY fit within the broader CRScube ecosystem?
cubeSAFETY works as part of the CRScube clinical technology ecosystem, helping connect safety reporting with clinical data capture and wider study operations. This creates a unified approach to case handling, oversight, and regulatory reporting.