Why ePRO Matters
Electronic Participant Reported Outcomes (ePRO), one type of electronic Clinical Outcome Assessment (eCOA), have become increasingly important in clinical trials. They address many of the challenges associated with traditional paper diaries, such as missing pages, retrospective data entry, and errors introduced when information is recorded after the fact. Beyond reducing these issues, ePRO systems foster clear communication and consistent reporting of outcomes between participants and study teams.
If you’re building your own ePRO instrument, take a look at our article on statistical validation.
Simplifying Patient Engagement
At S‑cubed Biometrics, we strive to make data collection straightforward, dependable, and easy for everyone involved. This is especially true for ePRO, which is why we use OpenClinica Participate. This module allows participants to enter their information via a simple link on a device they already use, a Bring Your Own Device (BYOD) approach. There are no apps to download and no need for the costly provision or management of standalone devices. For sponsors, this simplifies study setup and delivery. For participants, it reduces barriers to participation and increases compliance.
Real-Time Data Capture and Visibility
The Participate module integrates immediately and directly with the clinical database, commonly known as the EDC. By capturing data in real time and making it readily available, data management and clinical teams gain immediate visibility of participant reported information within the EDC. This timely access supports appropriate oversight of incoming data and helps identify potential issues early, strengthening participant safety. Automated reminders also encourage participant engagement without adding burden to site staff.
To support study start up and downstream approvals, our Data Management team produces PDF representations of unique eDiary screens at an early stage. These materials can be used during protocol development, ethics review, and regulatory submissions, helping to ensure diary requirements are clearly defined, feasible for participants, and approved prior to build.
Ensuring Quality from the First Entry
Our Data Management team plays a central role in the setup of ePRO and its seamless integration with the EDC. They design and configure eDiary forms to be intuitive for participants, while ensuring that study specific visit schedules and diary windows allow appropriate flexibility for real world scenarios. Built in validation checks help reduce incomplete or inconsistent entries, supporting cleaner data from the outset.
Throughout the study, our Data Managers closely monitor incoming ePRO data, respond quickly to issues, and ensure that data entering the database is accurate, complete, and ready for analysis. If the ePRO platform is the vehicle, our Data Managers are the specialists keeping it running reliably from start to finish.
By combining rapid eDiary build timelines, full EDC integration, and a BYOD delivery model, S-cubed Biometrics offers a cost efficient ePRO solution that delivers high data quality, promotes participant engagement, and contributes to efficient study delivery.