Pharmacovigilance
Accelerating safety system adoption at a global pharma
Training
Implementation
Safety reporting
Background
A mid-sized pharmaceutical company needed to replace a legacy pharmacovigilance (PV) system and adopt a modern safety database that could support global electronic reporting and a high volume of cases across clinical and post market activity.
They had three main areas of concerns:
Implementation timelineThe team wanted to avoid long setup cycles and reduce the internal effort required to get to a confident go live. |
Regulatory readinessThe system needed to support International Council for Harmonisation (ICH) E2B(R3) from day one, with reliable reporting preparation for global regulators and partners. |
Operational effortManual steps and duplicate entry created rework and made it harder to keep case data consistent across teams. |
In two weeks, CRScube's training and enablement gets PV teams up and running on cubeSAFETY.
Background
A mid-sized pharmaceutical company needed to replace a legacy pharmacovigilance (PV) system and adopt a modern safety database that could support global electronic reporting and a high volume of cases across clinical and post market activity.
They had three main areas of concerns:
Implementation timelineThe team wanted to avoid long setup cycles and reduce the internal effort required to get to a confident go live. |
Regulatory readinessThe system needed to support International Council for Harmonisation (ICH) E2B(R3) from day one, with reliable reporting preparation for global regulators and partners. |
Operational effortManual steps and duplicate entry created rework and made it harder to keep case data consistent across teams. |
Solution: cubeSAFETY
The company adopted cubeSAFETY as the safety database, with a focus on fast adoption and early operational confidence.
2 week implementation plan
From kick-off to go-live, the implementation was completed in 2 weeks, supported by a structured onboarding approach and testing in a dedicated sandbox environment before production.
Rapid configuration
Once the product list and reporting requirements were confirmed, the initial configuration was completed in 1 day, avoiding long specification cycles.
Workshop led onboarding
A Project Management led workshop completed the core configuration decisions in a short session of under 2 hours, so the team could validate workflows without heavy internal build effort.
Controlled case intake from the EDC
Where adverse events were captured in the Electronic Data Capture (EDC) system, key subject and event details could enter cubeSAFETY in a consistent format, reducing duplicate entry and supporting traceability.
Results
After go-live, the company achieved measurable operational improvements:
Faster time to adoptionThe PV team moved from kick-off to daily use in 2 weeks and noted that sandbox testing helped them feel confident before production. |
Reduced rework and improved consistencyThe client highlighted that standardised workflows and validations reduced avoidable corrections, and helped cases progress with fewer back-and-forth checks. |
Stronger reporting readinessThe team valued having ICH E2B(R3) support in place immediately, reducing manual preparation effort and supporting consistent outputs across regions. |
Additional benefits
Support
PV specialists particularly appreciated having an AI chatbot available when they were unsure how to complete a task efficiently, alongside online manuals and a complimentary help desk during early use.
Operational efficiency
The team reported fewer manual steps and less reconciliation work, which made coordination between PV and study teams easier during busy periods.
Scalability
Reusable configurations supported faster rollout across additional studies, without restarting setup from scratch.
Conclusion
By adopting cubeSAFETY with a workshop led approach and sandbox testing, this pharma team replaced a legacy safety system with minimal disruption. The result was faster adoption, clearer workflows, and a reporting ready foundation that supported their timelines and internal capacity.
In two weeks, CRScube's training and enablement gets PV teams up and running on cubeSAFETY.
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