Why Most ePROs Fail (and How We Achieve 90%+ Compliance Globally)

Introduction Electronic Patient-Reported Outcomes (ePROs) are crucial to capturing the patient voice in clinical trials. But while adoption of digital tools has surged, compliance and data quality remain persistent issues—jeopardizing timelines, inflating costs, and weakening trial outcomes.

In this post, we explore why most ePRO implementations underperform and how Delve Health takes a fundamentally different approach—leveraging mobile, web-based, and AI-enhanced tools to deliver >90% global compliance and higher patient retention.

The Problem: Most ePROs Were Built to Digitize Paper, Not Support Patients

Despite the promise of digital transformation, many ePRO platforms still feel like glorified paper forms. Key challenges include:

• Poor usability: Especially for older adults, non-English speakers, and tech-wary patients
• Low personalization: Generic notifications that don’t adapt to patient behavior or preferences
• Fragmented experiences: Multiple logins and disconnected tools
• Limited accessibility: Few platforms support offline use or multiple languages fluently

The result? Compliance drops, data quality suffers, and study teams spend too much time chasing entries.

Paper vs. Web vs. Mobile: Why Format Matters Less Than Experience

Let’s compare the three common ePRO collection methods:

• Paper-based PROs are familiar but inefficient. Data transcription delays, backfilled entries, and missing timestamps are common.
• Web-based ePROs work well for some populations but typically require stable internet, and most are not mobile-optimized.
• Mobile app-based ePROs offer real-time, on-the-go capture and can integrate wearables—but only if they’re designed with simplicity and support in mind.

Ultimately, format matters—but what matters most is the experience. Are patients supported? Is it intuitive? Can they engage without feeling overwhelmed?

The Hidden Costs of Poor Compliance

Low ePRO compliance isn’t just a data issue. It impacts the whole study:

• Sites spend hours weekly chasing incomplete forms
• Coordinators manually reconcile errors and resolve EDC discrepancies
• Sponsors face delays, inflated costs, and regulatory pushback due to incomplete data sets

Every dropout or delay is a risk to your trial’s success.

Regulatory Pressure Is Rising

Global regulators including the FDA and EMA now expect ePRO systems to be:

• Easy to use
• Fully auditable
• Secure and validated
• Proven to support engagement

It’s no longer enough to say you used digital tools—you have to prove they worked.

How Delve Health Delivers >90% Compliance in ePRO Studies

Delve Health’s ePRO platform is not a one-size-fits-all app. It’s a modular, patient-first system that combines:

1. Mobile + Web Access: Intuitive UX, offline capability, and responsive design for any device
2. Multilingual, Culturally-Sensitive Experience: Available in 65+ languages with localized UI
3. 32 AI-Powered Engagement Agents: Smart nudges, adaptive reminders, and real-time escalation if compliance drops
4. Unified Platform: eConsent, ePRO, wearables, and concierge support—all in one login
5. Human Support: 24/7 multilingual concierge helps patients through any barrier

How It Impacts Trial Success

When patients stay engaged:

• Data comes in clean and complete
• Sites focus on care, not reminders
• Sponsors meet milestones faster

We’ve helped reduce screen failures by 48% and increase engagement by up to 2x using this model.

Final Thoughts

Most ePRO tools fail because they prioritize data over experience. At Delve Health, we flipped the model: build around the patient, and the data will follow.

With over 90% compliance across 20+ countries, we’re helping sponsors modernize trials without losing the human connection.

Want to See It Live?

👉 Schedule a quick demo to see how we can support your next study. 

Contact us: contact@delvehealth.com | www.delvehealth.com