Product Overview
ePRO and eCOA are digital methods for collecting patient-reported outcomes and clinical outcome assessments in clinical trials. These tools allow patients, clinicians, and caregivers to directly report outcomes using electronic devices, such as smartphones, tablets, and wearables. This hybrid model can include BYOD (Bring Your Own Device) or fully configured devices provided by the trial, enabling real-time data collection and more granular endpoint data.
ePRO (electronic Patient Reported Outcomes): Patients report their own health status, symptoms, and overall well-being.
ePerfO (electronic Performance Outcomes): Patients perform tasks or activities, and the performance data is captured electronically.
eClinRO (electronic Clinician-Reported Outcomes): Clinicians record their observations and assessments electronically.
eObsRO (electronic Observer-Reported Outcomes): Caregivers or observers report their observations about the patient’s condition.
In recent years, there has been a significant shift towards patient-centric clinical trial designs. Approximately one-quarter of clinical trials today include patient-reported outcomes, a considerable increase from past decades. In 2014, about half of clinical trials still relied on paper forms for data collection. However, advancements in technology have demonstrated that electronic data collection not only improves the patient experience but also enhances data quality and reduces environmental impact by minimizing paper use.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Implementing ePRO and eCOA in Clinical Trials
The implementation of ePRO and eCOA in clinical trials begins with thoughtful trial design. Here’s how it works:
- Define Data Points and Feedback: The clinical research team identifies the specific data points and feedback required from patients.
- Choose the Best Format: The team decides on the best format for data collection, which may include an app, e-patient diary, wearable device, or other digital forms.
- Device Provision: Patients can either use devices provided by the trial or install an app like Clinical Study Pal on their own devices.
- Remote Monitoring: Once the ePRO/eCOA forms are completed, the research site can remotely monitor patient responses, enhancing patient compliance and overall trial experience.
About the company
We are a digital healthcare and clinical trials platform and services company that partners our technology solutions with companies and organizations that sponsor Phase I – IV studies. We welcome the opportunity to discuss how we can implement solutions that will automate your workflows and increase efficacy and patient retention.