What if clinical trials could get more participants by making the consenting process easier?

Project Overview

Role: Lead UX Designer (UX hire #2)
Timeline: 10 months
Team: Product Manager, 4 Engineers, Legal Team, SME Focus Group
Impact: Successfully launched IRB-compliant eConsent tool that achieved 98% task success rate and opened new market opportunity

Executive Summary

As the second UX hire at a fast-growing healthcare startup, I led the end-to-end design of a groundbreaking electronic consent platform for clinical research organizations. Working with strict regulatory requirements and a brand-new team, I transformed a complex 45-page paper process into an intuitive digital experience that helped reduce participant dropout—a major factor in medicine costs and lengthy clinical trials.

The Challenge

"She drove 2 hours for the clinical trial, completed her session, but forgot to sign the updated consent form. Due to IRB discrepancies, we lost her—and participants like her are incredibly hard to recruit."

This story from a colleague became our North Star. Participant dropout costs the clinical research industry billions annually, often due to cumbersome consent processes. Clinical Research Organizations (CROs) needed a digital solution, but it had to navigate:

  • Strict IRB regulations governing informed consent

  • Accessibility requirements (6th-grade reading level, diverse populations)

  • Complex versioning control to track consent form updates

  • Trust barriers between participants and research institutions

Project Constraints

  • Brand new market for the company

  • No direct user access (CROs protect participant privacy)

  • Regulatory compliance requirements from day one

  • Fast timeline with limited UX infrastructure

  • New engineering team unfamiliar with UX processes

Research & Discovery

Competitive Analysis: Learning from e-Signature Leaders

I conducted comprehensive UX audits of PandaDoc, DocuSign, and HelloSign, recording myself through both web and mobile experiences.

Key Insight: The "handwritten signature" simulation was crucial—without it, early test users were unsure if they'd actually signed anything.

SME Interviews: Understanding the Domain

Working with Product, I organized focus groups with 4 internal employees who previously worked directly with clinical consent forms.

Critical Discovery: Version control wasn't just nice-to-have—it was essential for regulatory compliance. The story of the participant who drove 2 hours only to be dropped due to version discrepancy highlighted our core value proposition.

Usability Testing Strategy

As a resource-constrained startup, I designed targeted testing focusing on our most vulnerable user groups:

  • 10 moderated sessions with elderly, ESL, and non-tech-savvy users

  • Semi-realistic consent forms to trigger authentic reactions (dummy text caused unrealistic behaviors)

  • Strategic content insertion to provoke specific user responses aligned with research goals

Design Strategy

Mobile-First Approach

Given accessibility requirements and the need to reach diverse populations, I designed mobile-first—not just as best practice, but as equity imperative.

Design Challenge: IRB regulations prohibit coercing participants. This meant:

  • Downplaying visual emphasis on affirmative CTAs

  • Maintaining neutral design language

  • Ensuring 6th-grade reading level comprehension

  • Rethinking traditional hierarchy and gestalt principles

Cross-Functional Collaboration Framework

I established new processes to integrate UX into the engineering workflow:

  • Weekly design workshops with Product, Legal, and Engineering

  • Parallel design-development tracks to maintain velocity

  • Regular design reviews encouraging teams to "poke holes" in designs

  • Updated scrum ceremonies to include UX touchpoints

Key Design Decisions

Version Control System

Created a clear visual framework for participants to understand:

  • What changed between consent versions

  • Why they need to re-consent

  • How their previous consent history is maintained

Accessibility-First Interface

  • High contrast ratios for vision accessibility

  • Large touch targets for motor accessibility

  • Clear information hierarchy without coercive design patterns

  • Progressive disclosure to manage cognitive load

Admin Dashboard Design

Collaborated with Legal team to map IRB approval workflows, creating an admin interface that:

  • Tracks consent version history

  • Monitors compliance status

  • Provides audit trails for regulatory review

Implementation & Testing

Pilot Customer Testing

Product and I worked with Sales to identify pilot customers for alpha testing, enabling:

  • Real-world feature validation with actual consent forms

  • Roadmap prioritization based on user feedback

  • Early market traction before full launch

Engineering Collaboration

Trained full-stack and backend developers on UX implementation:

  • Design handoff processes using detailed specifications

  • Component-based thinking for scalable development

  • Usability heuristics integrated into code review

Results & Impact

Quantitative Outcomes

  • 98% task success rate in moderated usability studies

  • 100% IRB compliance across all pilot implementations

  • On-time delivery despite complex regulatory requirements

  • Zero accessibility violations in final audit

Qualitative Impact

  • Positive pilot customer reception leading to expanded partnerships

  • New market entry for the company's product suite

  • Established UX processes that scaled to other products

  • Team capability building in UX collaboration

Business Value

  • Opened new revenue stream in clinical research market

  • Demonstrated company's ability to navigate regulated industries

  • Created repeatable framework for complex product development

  • Built trust with engineering team for future UX initiatives

Lessons learned

Working with Ambiguous Requirements

This project taught me to thrive in uncertainty by:

  • Building multiple hypothesis tracks simultaneously

  • Using SME knowledge as proxy for user research when direct access isn't possible

  • Creating feedback loops with pilot customers early and often

Regulatory Design Constraints

Learned that constraints can drive innovation:

  • Neutral design patterns can still be engaging and clear

  • Accessibility-first thinking benefits all users, not just target groups

  • Cross-functional collaboration is essential when domain expertise is distributed

Startup UX Leadership

As an early UX hire, I discovered the importance of:

  • Process evangelism alongside design craft

  • Quick wins to build team trust and UX credibility

  • Strategic thinking about product market fit while executing tactically

What's Next

The success of eConsent validated our approach to regulated healthcare products and established UX as a core competency. The processes and relationships built during this project became the foundation for the company's expanded healthcare product suite.

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