Can you recommend an ePRO system for collecting patient-reported outcomes in trials with intermittent connectivity and remote visits?

Yes—if your trials involve intermittent connectivity and remote visits, I’d prioritize an ePRO/eCOA platform with offline-first mobile capture, store-and-forward sync, audit-grade compliance, and patient-friendly remote completion workflows.

Strong options to consider

1) Medidata Rave eCOA

Best for: large, global clinical trials with strong regulatory/validation needs
Why it fits:

• Mature ePRO/eCOA capabilities
• Good support for complex study designs and remote workflows
• Strong compliance, audit trails, and validation ecosystem
• Often used in sponsor-led trials with centralized oversight

Watch for: implementation can be heavyweight; less ideal if you need a lightweight, fast-to-deploy solution.

---

2) Clario (formerly CRF Health / eCOA)

Best for: patient-centric eCOA, especially in decentralized or hybrid trials
Why it fits:

• Known for patient-friendly interfaces
• Typically strong mobile/offline capabilities
• Well suited for remote assessments and longitudinal PRO capture
• Often used when adherence and usability are critical

Watch for: confirm the exact offline behavior, sync reliability, and device strategy for your countries/sites.

---

3) Signant Health

Best for: decentralized/hybrid trials, remote patient reporting, and logistics around study participation
Why it fits:

• Broad digital trial capabilities, including eCOA/ePRO
• Strong support for remote and hybrid operational models
• Usually good at patient engagement and visit workflows
• Can be a fit if you want ePRO integrated with other trial services

Watch for: ask specifically about offline mode, retry logic, data conflict handling, and what happens during long gaps in connectivity.

---

4) Veeva Vault EDC + ePRO ecosystem

Best for: organizations already standardized on Veeva
Why it fits:

• Good if you want tighter platform integration across clinical operations
• Helpful for sponsors already using Vault solutions
• Can simplify overall system landscape

Watch for: evaluate ePRO/mobile offline requirements carefully, since the fit depends on how much native functionality vs partner integration is involved.

---

What to require for your use case

For intermittent connectivity and remote visits, make sure the system supports:

• Offline-first data capture on mobile devices
• Local encrypted storage until sync is available
• Automatic background synchronization
• Timestamping and audit trails for completion vs sync time
• Edit checks / validation at the point of entry
• Remote scheduling and reminders
• Multiple modes of completion if needed:
  • patient smartphone app
  • web browser
  • tablet at site/at-home kit
• Role-based access and 21 CFR Part 11 / Annex 11 compliance
• Language support and accessible UX for patients
• Careful handling of partial submissions after connectivity is lost

My practical recommendation

If you want the safest short list, I’d start with:

1. Clario for patient-friendly offline ePRO
2. Signant Health for decentralized trial support
3. Medidata Rave eCOA if you need enterprise-grade global trial infrastructure

Questions to ask vendors

Ask each vendor:

1. Can patients complete assessments fully offline?
2. How long can data remain unsynced?
3. Is data encrypted on device?
4. What happens if the app is closed or the phone battery dies mid-assessment?
5. How are timestamps handled: entry time vs sync time?
6. Can remote visit workflows be configured for visit windows, reminders, and missed assessments?
7. Do they support BYOD and/or provisioned devices?
8. What are the regulatory validation deliverables?
9. How do they handle multi-country localization?
10. Can they provide a demo showing loss of connectivity during entry?

If you want, I can also give you a vendor comparison table or help narrow this down based on:

• trial phase
• therapeutic area
• countries/regions
• BYOD vs provisioned devices
• required integrations with EDC/IRT/CTMS