How to Choose the Right ePRO Software

June 3, 2025

ePRO stands for electronic Patient-Reported Outcomes. It is software that allows patients to report how they feel or what symptoms they are experiencing during a clinical trial-using a phone, tablet, or computer. Instead of writing answers on paper, patients use ePRO to enter their responses directly into the system.

ePRO software is widely used in clinical trials because it helps collect more accurate, real-time data and improves patient engagement. It also reduces errors and saves time for both patients and clinical teams.

ePRO software is used to:

Collect data on symptoms, side effects, or quality of life directly from patients
Monitor patient progress throughout the study
Send reminders to patients to complete their questionnaires
Make sure the data is complete and ready for analysis faster than with paper forms

ePRO helps make clinical trials more efficient, more accurate, and more patient-friendly.

Why ePRO Matters in Clinical Research

Using ePRO software in clinical research brings many advantages compared to traditional paper-based methods. It helps improve the quality of data, makes it easier for patients to participate, and speeds up the whole process.

When patients report their experiences through ePRO, the information is recorded right away and safely stored. This makes the data more reliable and reduces the chances of losing or misreading it.

Benefits of using ePRO software:

More accurate data – no risk of lost papers or unclear handwriting
Faster access to data – responses are available in real time
Better patient experience – easy-to-use on mobile devices, no need for clinic visits just to fill out forms
Fewer errors – built-in checks help ensure patients answer all questions correctly
Improved compliance – automatic reminders help patients stay on schedule

ePRO plays a key role in modern clinical trials by making data collection smarter, faster, and more patient-friendly.

Key Features to Look For in ePRO Solutions

Not all ePRO systems are the same. When choosing the right ePRO software, it’s important to look at key features that support smooth and effective clinical trials.

A good ePRO solution should be easy for patients to use, meet all regulatory requirements, and work well with other clinical systems like EDC.

Important features to look for in ePRO software:

User-friendly design – simple interface for patients of all ages
Mobile accessibility – works on phones, tablets, or computers
Regulatory compliance – meets standards like 21 CFR Part 11 and GDPR
Real-time data access – immediate availability of patient responses
Reminders and notifications – helps patients stay on schedule
Multilingual support – for global studies
Easy integration – connects with EDC, CTMS, and other systems

When you choose EDC from Flex Databases, you can easily implement a scalable and fully integrated ePRO module. That means no extra setup, faster implementation, and smooth data flow between systems, making trial management easier for your team and participation easier for your patients.

Regulatory Compliance and Data Security

In clinical trials, protecting patient data and following regulations is a must. ePRO software must meet strict global standards to ensure that the information collected is secure, accurate, and accepted by regulatory bodies.

Choosing an ePRO solution that follows these rules helps avoid risks, delays, and rework during inspections or submissions.

Key standards your ePRO software should meet:

21 CFR Part 11 – ensures electronic records and signatures are secure and trustworthy
GDPR – protects personal data of patients in the EU
ICH E6(R2) – sets expectations for electronic systems in clinical trials
Data encryption and secure storage – to keep patient data safe at all times
Audit trails – to track changes and show who did what and when

At Flex Databases, our ePRO solution is fully compliant with these standards, giving clients confidence that both data quality and data privacy are well protected.

Patient Usability and Accessibility

For ePRO software to work well, patients need to find it easy and comfortable to use. A simple, clear interface helps patients complete questionnaires without confusion or frustration. If the software is hard to use, it can lead to incomplete or incorrect data.

Accessibility also means making the software available to a wide range of patients, no matter their language or device.

Important usability and accessibility features include:

Simple and intuitive design – easy navigation for patients of all ages and tech skills
Mobile-friendly – works smoothly on smartphones and tablets
Multilingual support – available in multiple languages for global studies
Clear instructions and help options – to guide patients through each step
Accessibility features – support for visually impaired or disabled users

Good usability and accessibility improve patient participation, compliance, and data quality in clinical trials

Integration with Other Clinical Systems

In modern clinical trials, different software systems need to work together smoothly. ePRO software should easily connect with other tools like CTMS, EDC, and eConsent to provide a complete view of the trial data.

Good integration helps avoid duplicate data entry, reduces errors, and saves time for study teams.

Key integration points to consider:

Clinical Trial Management System – for managing study timelines and tasks
Electronic Data Capture– for clinical data collection and management
Other tools – like safety reporting or monitoring platforms

Our ePRO can be seamlessly connected with all other Flex Databases tools, as well as the tools you’re already using. This full integration means better data flow, easier management, and a smoother clinical trial experience.

Vendor Support and Implementation Process

Choosing the right ePRO software is not just about features – good vendor support is just as important. A reliable vendor helps your team get started quickly and solves problems along the way.

Flex Databases provides full support during the entire implementation process. From training and onboarding to ongoing customer service, we make sure your team feels confident and ready to use the system.

What you can expect from Flex Databases support:

Personalized training to help your staff learn how to use ePRO and other tools
Smooth onboarding with guidance tailored to your study needs
Dedicated customer support available to answer questions and fix issues fast
Timely implementation so you can meet your project deadlines without delays

With Flex Databases, you get a partner that stands by you from day one until your trial is complete.

Common Pitfalls to Avoid

Choosing the wrong ePRO software can cause delays, extra costs, and frustration. Many sponsors and CROs make similar mistakes that can be avoided with careful planning.

Common pitfalls to watch out for:

Ignoring patient usability – picking a system that is hard for patients to navigate leads to low completion rates
Overlooking integration needs – choosing ePRO that doesn’t work well with your EDC or CTMS creates extra work
Not checking compliance thoroughly – using software that doesn’t meet regulatory requirements risks data rejection
Underestimating training and support needs – poor vendor support can cause delays and confusion
Choosing a one-size-fits-all system – not all ePRO solutions scale well for different study sizes or regions
Focusing only on cost – cheapest options may lack important features or quality

Avoid these pitfalls by carefully reviewing your needs, testing software early, and working with a vendor that offers full support and integration.

Final Checklist for Selecting ePRO Software

Before choosing your ePRO software, make sure it meets all these important points:

User-friendly for patients – easy to use on phones, tablets, and computers
Fully compliant with regulations like 21 CFR Part 11 and GDPR
Integrates smoothly with your EDC, CTMS, eConsent, and other systems
Supports multiple languages and accessibility needs
Provides real-time data access and automated reminders
Offers strong vendor support including training, onboarding, and ongoing help
Scalable and flexible to fit studies of all sizes and types
Secure data storage with audit trails and encryption
Fits your budget without sacrificing important features or quality

If you choose ePRO from Flex Databases, it can be easily integrated with our EDC and other tools, giving you a scalable solution and expert support to help your trial succeed.

Use this checklist to compare options and find the right ePRO software for your clinical trial needs.