Full editorial redesign of Informed Consent Forms (ICFs), resulting in Plain-language ICF Summaries that achieved a 9th-grade readability score for easier decision-making.
A global sponsor's Phase III materials consistently tested at a 15th-grade reading level, creating a significant barrier to understanding for the target demographic and increasing the sponsor's regulatory risk. The materials lacked empathy in their presentation, which is key to successful project outcomes.
Craig Taylor
Top-Tier Global Sponsor / Phase III Trial
"We needed to simplify the complex regulatory language without losing compliance. Trial Empathix delivered ICF summaries that our patients actually read and understood, fundamentally improving the quality of our consent process."
Team behind Poppin
What we did
Reduced readability score from 15th-grade to 9th-grade level; 25% faster review time by site staff; Improved patient confidence in decision-making reported via site feedback.
13
Pages
5
CMS Layouts
6
Breakpoints
Project approach
We applied a systems-based approach to content strategy. We transformed the mandatory ICF content into layered Plain-Language ICF Summaries and FAQ sheets. Our writing team stripped away jargon, used active voice, and visually highlighted "must-know" information, ensuring the core messages were immediately clear.
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