As clinical trials grow increasingly complex and decentralised, one truth remains constant: patient engagement is vital to study success. However, capturing patient-reported outcomes (PROs) has long been a challenge, often relying on paper forms, third-party apps, or disconnected systems that slow down data flow and increase the risk of errors.
Today, this is changing.
An important shift is underway across the clinical research landscape: the integration of electronic Patient-Reported Outcomes (ePROs) directly within Electronic Data Capture (EDC) platforms. And it’s already reshaping how patients, sites, and sponsors interact.
Why ePRO integration matters
Traditionally, collecting PROs has meant introducing separate systems or relying on non-standardised tools. While digitalisation has improved this, many clinical trials still treat ePROs as a parallel process, an add-on rather than a core part of the study architecture.
By embedding ePRO functionality directly within an EDC system, sponsors and CROs can now benefit from:
- Unified data environments: ePRO and site-entered data are stored together, improving consistency and reducing reconciliation needs
- Real-time access: Investigators can view patient-submitted data as it arrives, enabling quicker decisions and early interventions
- Improved usability: Patients engage with the same streamlined interface throughout the trial, increasing adherence
- Regulatory alignment: Integrated systems facilitate audit readiness and full compliance with EMA, FDA, and ICH-GCP requirements
This shift is more than a technical upgrade, it’s a meaningful improvement to the patient experience and data reliability.
Patient engagement begins with design.
A well-integrated ePRO system allows participants to report symptoms, experiences, and outcomes from the comfort of their homes, often using their own devices. This convenience doesn’t just support decentralised trials; it makes patients feel more included in the research process.
When ePRO tools are intuitive, accessible, and seamlessly integrated, patients are more likely to respond consistently and accurately. This in turn leads to:
- Higher-quality data
- Faster analysis
- Stronger insights into treatment impact
This isn’t just good science: it’s better care.
Xolomon: making research accessible
At Xolomon, we recognise that effective ePRO integration is essential for modern trials. That’s why our X5 platform allows research teams to design, manage, and analyse ePROs natively, without needing third-party tools or external development.
Sponsors can build eCRFs and ePROs in the same environment, tailor them to each study’s needs, and monitor real-time submissions—all with full control and autonomy.
And for patients? It’s one clear, easy-to-use system that keeps them informed, involved, and engaged.
Final thoughts
As the industry continues to embrace decentralised models and patient-centric approaches, ePRO integration within EDC platforms is no longer a luxury, it’s a necessity. It simplifies operations, enhances regulatory compliance, and most importantly, puts the patient voice where it belongs: at the centre of the trial.
To learn how Xolomon can help you streamline your ePRO strategy, get in touch at info@xolomon.com or visit www.xolomon.com
