Frequently Asked Questions (FAQs) About ePRO for Sponsors, CROs, and Specific Therapeutic Areas

1. General ePRO Overview

1.1 What is ePRO?

ePRO (Electronic Patient-Reported Outcome) is a digital method for capturing patient-reported health data in clinical trials using electronic devices like smartphones, tablets, or web-based portals. It replaces traditional paper-based methods, ensuring more accurate, real-time data collection.

1.2 Why is ePRO important for clinical trials?

ePRO improves:
✅ Data accuracy – Eliminates transcription errors.
✅ Patient compliance – Automated reminders ensure timely data entry.
✅ Regulatory compliance – Supports 21 CFR Part 11, ICH-GCP, and GDPR.
✅ Remote monitoring – Enables Decentralized Clinical Trials (DCTs).
✅ Cost efficiency – Reduces site visits and manual data entry.

1.3 What types of clinical trials and therapeutic areas benefit most from ePRO?

ePRO is widely used in:

• Oncology – Captures patient-reported pain levels, fatigue, and quality of life.
• Cardiology – Tracks symptoms like shortness of breath, palpitations, and exercise tolerance.
• CNS Disorders (Neurology, Psychiatry) – Monitors depression, cognitive decline, seizure frequency.
• Respiratory Diseases – Collects data on asthma and COPD symptoms, medication adherence.
• Rare Diseases – Helps with remote patient monitoring and long-term follow-ups.
• Chronic Pain Management – Tracks pain severity, medication efficacy, and side effects.
• Gastrointestinal Disorders – Monitors IBS, Crohn’s disease, and ulcerative colitis symptoms.

2. Regulatory Compliance and Data Security

2.1 Is ePRO data accepted by regulatory authorities?

Yes, ePRO is accepted by the FDA, EMA, and PMDA, provided it adheres to:

• 21 CFR Part 11 (FDA) – Electronic records and signature compliance.
• ICH-GCP – Ensures ethical and quality trial standards.
• GDPR (Europe) & HIPAA (U.S.) – Protects patient data privacy.
• ISO 27001 – Information security management compliance.

2.2 How does Cloudbyz ePRO ensure regulatory compliance?

Cloudbyz ePRO is natively built on Salesforce, offering:
🔒 End-to-end encryption for data security.
📝 Electronic signatures & audit trails for compliance.
📊 Real-time data monitoring for study teams.

2.3 How does ePRO ensure data integrity and security?

Cloudbyz ePRO ensures:

• Two-factor authentication (2FA) for patient logins.
• Role-based access control (RBAC) to protect sensitive data.
• Tamper-proof audit trails that log all changes.
• Data redundancy & backup to prevent data loss.

3. Deployment and Integration

3.1 How is ePRO deployed in clinical trials?

Patients access Cloudbyz ePRO through:
📱 Mobile apps (iOS & Android) – User-friendly interfaces for real-time data entry.
💻 Web-based portals – Browser access for diverse patient demographics.
⌚ Wearables & IoT devices – Passive data collection for continuous monitoring.

3.2 Can ePRO integrate with other clinical trial technologies?

Yes! Cloudbyz ePRO seamlessly integrates with:
🔹 EDC (Electronic Data Capture) – Real-time data transfer to clinical databases.
🔹 CTMS (Clinical Trial Management System) – Provides study-wide oversight.
🔹 eTMF (Electronic Trial Master File) – Automates compliance documentation.
🔹 EHR (Electronic Health Records) – Enables cross-referencing with patient history.

3.3 How does Cloudbyz ePRO support Decentralized Clinical Trials (DCTs)?

• Remote patient monitoring – Reduces need for site visits.
• Automated alerts & reminders – Boosts compliance in at-home settings.
• Multi-device access – Patients can use their own smartphones, tablets, or computers.
• Wearable integrations – Supports real-time symptom tracking for chronic conditions.

4. Patient Engagement and Compliance

4.1 How does ePRO improve patient compliance?

💡 Automated reminders & notifications – Reduces missed entries.
📊 Gamification & progress tracking – Encourages engagement.
🌍 Multi-language support – Enhances accessibility for global trials.
🔄 BYOD (Bring Your Own Device) support – Allows easy adoption.

4.2 How does Cloudbyz ePRO handle missing or incomplete data?

• Auto-generated alerts notify study teams of missing entries.
• Conditional logic prompts patients to complete assessments.
• Retrospective data entry options reduce missing data rates.

4.3 Can ePRO accommodate visually impaired or disabled patients?

Yes, Cloudbyz ePRO complies with:
✔ WCAG (Web Content Accessibility Guidelines) for screen readers.
✔ Customizable font sizes & color contrast for readability.
✔ Voice-to-text functionality for data entry.

5. Cost, ROI, and Adoption Challenges

5.1 How does ePRO reduce clinical trial costs?

💰 Eliminates data transcription costs from paper-based methods.
⏳ Reduces site visits by enabling remote data collection.
📊 Minimizes protocol deviations by improving patient compliance.
⚡ Accelerates trial timelines through real-time insights.

5.2 What are the challenges of ePRO adoption?

• Regulatory hurdles – Compliance with multiple global agencies.
• Patient digital literacy – Providing adequate training for older populations.
• Device compatibility – Ensuring access across different platforms.

5.3 How does Cloudbyz ePRO address these challenges?

✔ Configurable to meet regional regulatory needs
✔ Intuitive UI/UX for diverse patient populations
✔ Multi-device & offline support for seamless data capture

6. ePRO Customization for Specific Therapeutic Areas

6.1 How is ePRO customized for Oncology trials?

📊 Tracks pain levels, fatigue, nausea, and quality of life.
💡 Enables early detection of adverse events in treatment cycles.
💻 Integrates with EDC and eTMF for streamlined data management.

6.2 How is ePRO optimized for Cardiology trials?

💖 Tracks shortness of breath, palpitations, and exercise tolerance.
📡 Integrates with wearable ECG devices for real-time monitoring.
📊 Provides trend analysis for early intervention.

6.3 How is ePRO tailored for CNS (Neurology & Psychiatry) trials?

🧠 Tracks seizure activity, mood fluctuations, and cognitive function.
🔄 Supports daily, weekly, and monthly symptom tracking.
💬 Uses interactive question logic for psychiatric assessments.

6.4 How is ePRO adapted for Rare Disease studies?

📝 Captures long-term symptom progression with minimal patient burden.
📡 Supports remote monitoring for geographically dispersed patients.
📊 Enables real-time alerts for worsening conditions.

7. Why Choose Cloudbyz ePRO?

7.1 How is Cloudbyz ePRO different from other solutions?

✅ Natively built on Salesforce for seamless clinical trial workflow automation.
✅ Configurable & scalable for all therapeutic areas.
✅ AI-powered insights for predictive analytics.
✅ Seamless integration with CTMS, EDC, eTMF, and Safety systems.

7.2 How can sponsors and CROs get started with Cloudbyz ePRO?

🚀 Fast deployment & expert onboarding
🛠️ Configurable dashboards for study-specific tracking
📞 24/7 technical support for global studies