Frequently Asked Questions (FAQs) About ePRO for Sponsors, CROs, and Regulatory Teams

1. General ePRO Overview

1.1 What is ePRO?

ePRO (Electronic Patient-Reported Outcome) is a digital method for collecting patient-reported health data in clinical trials. It enables patients to submit data on symptoms, quality of life, medication adherence, and treatment experiences via electronic devices like smartphones, tablets, or web-based portals.

1.2 How does ePRO benefit sponsors and CROs?

ePRO offers several advantages, including:

• Higher data accuracy – Eliminates transcription errors common in paper-based methods.
• Real-time monitoring – Enables sponsors and CROs to track patient data instantly.
• Automated compliance tracking – Reduces missing data and enhances regulatory adherence.
• Improved patient engagement – Digital tools encourage higher participation and retention.
• Cost efficiency – Reduces administrative burden and site visits for data collection.

1.3 What are the key use cases of ePRO in clinical trials?

• Phase I-IV clinical trials (pharmaceutical, biotechnology, medical device research)
• Observational studies (long-term patient monitoring and safety surveillance)
• Post-market surveillance (tracking adverse effects and quality-of-life assessments)
• Decentralized and hybrid trials (remote patient monitoring)

2. Compliance and Regulatory Considerations

2.1 What regulatory requirements apply to ePRO solutions?

ePRO must comply with various global regulations, including:

• 21 CFR Part 11 (FDA): Ensures electronic records are secure and auditable.
• ICH-GCP (Good Clinical Practice): Establishes ethical and quality standards.
• GDPR (Europe) and HIPAA (U.S.): Protect patient data privacy and security.
• ISO 27001: Ensures robust information security management.

2.2 Is ePRO data accepted by the FDA and EMA?

Yes, the FDA, EMA, and PMDA accept ePRO data when it meets compliance standards, is validated, and follows ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principles.

2.3 How does ePRO ensure data integrity and security?

• End-to-end encryption to protect data during transmission and storage.
• Role-based access control (RBAC) ensures that only authorized personnel can view or modify data.
• Audit trails and timestamps track every patient entry and modification.
• Electronic signatures provide authentication and compliance with regulations.

2.4 How does Cloudbyz ePRO ensure compliance?

Cloudbyz ePRO is built natively on Salesforce, ensuring:

• Automated compliance checks for 21 CFR Part 11 and GCP.
• Secure, cloud-based infrastructure with encryption and audit trails.
• Seamless regulatory reporting with real-time dashboards.

3. Deployment and Integration

3.1 How is ePRO deployed in clinical trials?

Sponsors and CROs provide access to ePRO systems via:

• Mobile apps (iOS & Android) for patient self-reported outcomes.
• Web-based portals for clinicians and trial coordinators.
• Wearables and IoT devices for passive health tracking.

3.2 Can ePRO integrate with other clinical trial technologies?

Yes, Cloudbyz ePRO seamlessly integrates with:

• Electronic Data Capture (EDC): Syncs patient-reported outcomes with study databases.
• Clinical Trial Management Systems (CTMS): Provides real-time trial oversight.
• eTMF (Electronic Trial Master File): Ensures compliant document storage.
• Electronic Health Records (EHRs): Enables data cross-referencing for deeper insights.

3.3 Does Cloudbyz ePRO support real-time analytics and dashboards?

Yes, Cloudbyz ePRO provides real-time monitoring dashboards that allow sponsors and CROs to track patient adherence, missing data, and trends in patient-reported outcomes.

3.4 How does Cloudbyz ePRO support decentralized trials?

• Remote data collection minimizes patient site visits.
• BYOD (Bring Your Own Device) support increases accessibility.
• Automated reminders and notifications ensure high patient compliance.
• AI-driven insights help analyze trends and early safety signals.

4. Patient Engagement and Compliance

4.1 How does ePRO improve patient compliance?

• Automated reminders ensure patients complete assessments on time.
• User-friendly interfaces make digital forms intuitive and accessible.
• Multilingual support enables diverse patient participation.
• Integration with wearables allows passive data collection without manual input.

4.2 What happens if a patient misses an ePRO assessment?

• Cloudbyz ePRO triggers automated follow-up alerts via SMS, email, or app notifications.
• Study coordinators receive real-time alerts to take corrective action.
• Data capture rules allow retrospective entry, ensuring minimal data gaps.

4.3 Can patients access ePRO on their own devices?

Yes, Cloudbyz ePRO supports BYOD (Bring Your Own Device), allowing patients to use personal smartphones, tablets, or computers for data entry, reducing hardware costs for sponsors.

4.4 How does Cloudbyz ePRO ensure accessibility for all patients?

Cloudbyz ePRO complies with WCAG (Web Content Accessibility Guidelines) and provides:

• Voice-to-text functionality for visually impaired users.
• Customizable font sizes and contrast settings for readability.
• Mobile and web-based options for accessibility across devices.

5. Cost, ROI, and Adoption Challenges

5.1 What are the cost savings of using ePRO compared to paper-based PRO?

• Eliminates costs related to data transcription and paper handling.
• Reduces trial timelines by enabling real-time data capture.
• Minimizes site visits, saving on logistics and site monitoring.
• Enhances data quality, reducing costly protocol deviations.

5.2 What challenges do sponsors and CROs face in adopting ePRO?

• Regulatory concerns – Ensuring compliance with global standards.
• Integration complexities – Connecting ePRO with existing clinical systems.
• Patient technology adoption – Overcoming digital literacy barriers.

5.3 How does Cloudbyz ePRO accelerate clinical trial efficiency?

• Configurable workflows reduce implementation time.
• AI-powered analytics detect patterns in patient-reported data.
• Seamless integrations with CTMS, EDC, and eTMF streamline operations.
• Real-time alerts enhance patient compliance monitoring.

6. Why Choose Cloudbyz ePRO?

6.1 How is Cloudbyz ePRO different from other ePRO solutions?

Cloudbyz ePRO is:
✅ Built natively on Salesforce for seamless clinical trial workflow automation.
✅ Fully configurable to support study-specific requirements.
✅ Designed for global trials with multi-language and compliance support.
✅ Integrated with Cloudbyz CTMS, eTMF, and EDC for unified trial management.
✅ AI-powered for advanced analytics and predictive insights.

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

Cloudbyz provides:
✔ Rapid deployment options for quick study launch.
✔ Expert support teams for onboarding and regulatory compliance.
✔ Configurable dashboards for trial-specific monitoring needs.