Global Unity Study

Applied Globalisation & Cultural Adaptation to validate study materials across 12 regions, ensuring regulatory compliance and cultural consistency for a multinational cardiovascular program.

Project overview

A large-scale cardiovascular outcome trial enrolling patients across Europe and Asia required uniform, culturally sensitive materials for complex patient populations, including those with impaired capacity or from marginalized populations. Generic translation often missed nuanced patient needs.

Kelsey Baine

Top-5 Global Pharmaceutical / Phase IV (Post-Market)

"Their team didn't just translate our materials; they culturally validated them. This attention to regional detail was key to accelerating our global site activation and maintaining consistency in our patient experience."

Team behind Poppin

What we did

100% regulatory approval for all patient-facing materials across 12 countries; 50% reduction in local site queries regarding material accuracy; Accelerated site start-up in three key markets.

14

Pages

6

CMS Layouts

2

Awards

Project approach

We managed the end-to-end Globalisation & Cultural Adaptation process. This included local validation, back-translation, regional readability checks, and adapting graphical instructions for cultural compliance in 12 languages. This ensured the complex consent process was managed effectively across diverse sites.
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