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Usability for Clinical Trials
Usability

Usability for
Clinical Trials

Patient Understanding is a Regulatory Requirement. Not a Guess.

01

Key Offerings

  • Patient Information Sheets (PIS) Testing

  • Informed Consent Form (ICF) Validation

  • Study Instructions and Flow Testing

  • Participant Diary or ePRO WalkthroughsParticipant Diary or ePRO Walkthroughs

  • Plain Language Trial Summary

02

  • EMA Guideline on ICF Readability (2021)

  • FDA Health Literacy Principles

  • ISO/IEC Usability for Patient-Facing Tools

03

  • 20-30 user interviews per geography

  • Real patient segments (age, literacy, digital fluency)

  • Reports for IRB/EC & Sponsor Submission

Digital Health And HealthTech

Digital Health &
HealthTec

Digital Doesn’t Mean Intuitive. We Prove It Is.

01

Focus Areas

  • eConsent and ePRO Usability

  • DCT (Decentralized Trial) Tool Interfaces

  • Mobile App Navigation Testing

  • HCP Portal Readability

  • Elderly or low-digital-literacy Testing

02

  • Early-stage Figma Click Testing

  • In-app A/B Testing (Prototype + Functional)

  • Remote or On-site Moderated Testing

  • Comparative UI/UX Clarity Metrics

Digital Health And HealthTech
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