Managed the Globalisation & Cultural Adaptation of core documents across nine languages, ensuring consistency and regulatory compliance for a multinational trial.
A major sponsor launched a global Phase III study, but local markets reported inconsistencies and cultural misalignments in patient-facing materials. This risked diluting the brand message and slowing down site activation across diverse regulatory environments. A project description summary was needed to align stakeholders.
Kelsey Baine
Global CRO & Biotech Partner / Phase III
"We needed fast, accurate, and culturally intelligent adaptation at scale. Trial Empathix delivered a global content strategy that dramatically streamlined our site activation without compromising quality or local patient trust."
Team behind Poppin
What we did
100% successful regulatory material submission across all nine regions; 40% reduction in time spent by the sponsor's review committee on final material approval; Standardised patient experience worldwide.
7
Pages
6
CMS Layouts
3
Awards
Project approach
We established a centralized translation and cultural adaptation process based on a defined project plan. We executed comprehensive back-translation and regional validation checks for the Trial Companion Kit, retention newsletters, and ICF summaries in nine languages. This ensured all patient communications were locally resonant and globally compliant.
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