Pharmacovigilance
Improving case reporting by connecting cubeSAFETY with cubeCDMS
EDC integration
Regulatory submission
Safety reporting
Background
A mid-size biotech needed a safer and more efficient way to move adverse event data from their Electronic Data Capture (EDC) system into their safety database. Case intake relied on manual exports, email attachments, and duplicate entry, which slowed reporting and increased risk.
They had three main areas of concerns:
Manual data inputSafety teams copied subject and event details from the EDC into the safety system, increasing handling time and the chance of transcription errors. |
Data consistency and traceabilityMismatches between systems created reconciliation work and made preparation for submission difficult and data quality issues. |
Submission readinessConfiguring ICH E2B(R3) exports and partner reporting around manual intake was costly and hard to scale across new studies. |
A mid-size biotech needed a safer and more efficient way to move adverse event data from their Electronic Data Capture (EDC) system into their safety database.
Background
A mid-size biotech needed a safer and more efficient way to move adverse event data from their Electronic Data Capture (EDC) system into their safety database. Case intake relied on manual exports, email attachments, and duplicate entry, which slowed reporting and increased risk.
They had three main areas of concerns:
Manual data inputSafety teams copied subject and event details from the EDC into the safety system, increasing handling time and the chance of transcription errors. |
Data consistency and traceabilityMismatches between systems created reconciliation work and made preparation for submission difficult and data quality issues. |
Submission readinessConfiguring ICH E2B(R3) exports and partner reporting around manual intake was costly and hard to scale across new studies. |
Solution: cubeSAFETY
The sponsor connected cubeSAFETY with cubeCDMS, CRScube’s EDC solution, allowing adverse event data to enter the safety workflow directly from the eCRF.
Case reporting efficiency
Individual Case Safety Report (ICSR) creation could be pre-populated with subject, visit, event, lab, and concomitant medication data captured in the EDC. Safety users completed clinical assessment, narratives, causality, and seriousness in cubeSAFETY, with e-signatures and full audit trail.
Native data exchange
Secure data flow from the EDC to cubeSAFETY reduced duplicate entry and maintained consistent identifiers across systems. Attachments from the EDC (for example, labs or source PDFs) could easily be referenced in the safety record to support medical review.
Data compatibility
They were able to leverage cubeCDMS and cubeSAFETY AI-supported medical coding, with MedDRA and WHO Drug. They also accelerated their safety submission thanks to built-in validations and case checks alignment with ICH E2B(R3) and local regulations.
Results
After enabling the connection, the company achieved measurable operational gains:
Faster case intake and submissionPre-populated ICSRs reduced handling time and helped cases progress to medical review and reporting sooner. |
Improved data qualityConsistent keys and automatic field mapping lowered reconciliation findings and reduced safety–clinical data mismatches. |
Better oversightSafety and clinical teams worked from aligned data, with clear traceability from the EDC record to the submitted ICSR. |
Additional benefits
Compliance
Role-based access, e-signatures, and a complete audit trail was a clear benefit in support of inspection readiness and ongoing PV obligations.
Operational efficiency
The client’s teams appreciated having less rework for data entry and reconciliation, fewer avoidable queries, and simpler coordination across study teams.
Scalability
Reusable mappings made rolling submission process out for additional protocols simpler, helping new studies adopt the same case flow quickly.
Conclusion
By connecting cubeSAFETY with cubeCDMS, the sponsor replaced manual transfers with a controlled data flow from the EDC into the safety reporting system. The result was faster case handling, higher data accuracy, and clearer end-to-end traceability from data entry to authority submission.
A mid-size biotech needed a safer and more efficient way to move adverse event data from their Electronic Data Capture (EDC) system into their safety database.
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