DATATRAK ePRO/eCOA Solution Expands Decentralized Trial Platform

Rhea-AI Summary

DATATRAK (NASDAQ: DTRK) launched an enhanced device-agnostic ePRO/eCOA solution on March 10, 2026, for hybrid and decentralized clinical trials. The module is BYOD-capable, offers email/SMS reminders, a secure patient portal, and unified reporting across EDC and eDiaries, deployable standalone or fully integrated with DATATRAK EDC.

The platform supports enrollment from the EDC, configurable notifications, and regional database hosting in the United States, Japan, and Europe, enabling global studies while aligning with local data privacy and security requirements.

Positive

• Device-agnostic BYOD support reduces participant barriers and potential study costs
• Native integration with DATATRAK EDC creates a unified environment for data capture and trial operations
• Email/SMS reminders and a secure patient portal improve participant engagement and completion visibility
• Unified reporting across eDiaries and EDC enables combined compliance and clinical data analysis
• Regional database hosting in United States, Japan, and Europe supports global study requirements

Negative

• None.

Device‑agnostic ePRO that is BYOD (bring your own device) with email/SMS reminders, patient portals, and unified reporting across EDC and eDiaries

AUSTIN, TX / ACCESS Newswire / March 10, 2026 / DATATRAK Powered by Fountayn, a unified eClinical and decentralized clinical trial (DCT) platform, today announced the availability of its enhanced electronic patient‑reported outcomes (ePRO) and eCOA solution, designed to help sponsors, CROs, and sites collect high‑quality patient data for hybrid and decentralized clinical trials. Built on DATATRAK's core eClinical platform, the ePRO module can be deployed as a standalone solution or tightly integrated with the DATATRAK EDC to support end‑to‑end digital trials.​​

DATATRAK ePRO is a device‑agnostic, true BYOD solution that allows patients to use their own smartphones, tablets, or computers, reducing study costs and barriers to participation. Study teams can configure eDiaries and electronic clinical outcome assessments (eCOA) using the same eCRF design toolkit they rely on for EDC casebooks, enabling faster start‑up and consistent design across all data capture tools.​

"Our customers want ePRO that is flexible, affordable, and fully connected to their EDC - not another silo," said Alex Tabatabai, CEO, DATATRAK Powered by Fountayn. "With DATATRAK ePRO, sponsors and CROs can design and launch eDiaries and eCOA quickly, send automated email and SMS reminders, and analyze compliance alongside EDC casebook data, all within a single, unified platform."​

Standalone ePRO or Fully Integrated with EDC

DATATRAK's ePRO solution is built on the same core platform as its EDC, RTSM, CTMS, eTMF, and eConsent tools. Customers can:​

1. Use ePRO as a standalone product and integrate with third‑party EDC or clinical trial systems, or

2. Add ePRO as a native extension of the DATATRAK EDC to create a unified environment for data capture, randomization, and trial operations.​​

Sites can invite and enroll ePRO participants directly from the EDC, link patient‑reported outcome data to subject records, and trigger one‑time notifications from within the EDC workflow. This tight integration helps reduce manual reconciliation and improves data quality across the study lifecycle.​

Patient Engagement Through Email/SMS and Secure Portal

To support patient engagement and compliance, DATATRAK ePRO includes:​

1. Email and SMS notifications to remind participants when eDiary or eCOA entries are due

2. A patient portal with secure PIN sign‑in so participants can easily access their tasks and forms

3. Configurable one‑time notifications sent from the EDC to specific participants or cohorts

These communication tools help improve completion rates and provide sites with better visibility into participant status in real time.​​

Unified Reporting Across eDiaries and EDC

Flexible reporting tools span both EDC casebooks and eDiaries, enabling study teams to build compliance and performance reports that incorporate patient‑reported outcomes alongside other clinical data. This unified view supports better decision‑making, early signal detection, and streamlined preparation for data reviews and regulatory inspections.​

With databases hosted in key regions including the United States, Japan, and Europe -and options for additional local data hosting-DATATRAK Powered by Fountayn supports global studies while aligning with regional data privacy and security requirements.​​

About DATATRAK

Datatrak is transforming healthcare and life sciences through technological innovations from providing the first EDC technology to offering the first true eSource solution that seamlessly integrates all aspects of clinical trial data management including EDC, RTSM, RBM, eTMF, CTMS, ePRO, eConsent, Endpoint Adjudication, Imaging Data, Safety, Inventory Management, and Enterprise Management of Automated Alerts, Workflows, Documents, Timelines, and Global Oversight. No other company has been innovating in healthcare and life sciences as long as Datatrak. For over thirty years clinical trial professionals have trusted Datatrak for reliable and secure technology solutions. Datatrak complies with the highest Quality Assurance standards that are 21 CFR Part 11, GDPR, GCP, HIPAA, and CDISC compliant that are fully validated by our experienced team of software quality engineers. Datatrak's cloud-based platform is trusted in 83 countries, 6 continents, for over 10,000 clinical trials. Datatrak is based in Austin, Texas and has team members and data hosting infrastructure in its key service regions of the United States, Europe, and Japan. For more information, visit www.datatrak.com or www.fountayn.com.

Contact:

Sales Department
sales@fountayn.com

SOURCE: Datatrak International

View the original press release on ACCESS Newswire

FAQ

What did DATATRAK (DTRK) announce about its ePRO/eCOA solution on March 10, 2026?

DATATRAK announced a device-agnostic ePRO/eCOA module available standalone or integrated with EDC. According to the company, the solution is BYOD-capable, offers email/SMS reminders, a secure patient portal, and unified reporting across EDC and eDiaries.

How does the DATATRAK DTRK ePRO support participant engagement and compliance?

The ePRO uses automated email and SMS reminders plus a secure portal for task access. According to the company, configurable notifications and PIN-protected portals increase completion rates and give sites real-time participant visibility.

Can sponsors use DATATRAK DTRK ePRO with third-party EDC systems or only DATATRAK EDC?

Customers can deploy ePRO standalone or as a native DATATRAK EDC extension. According to the company, the module integrates with third-party EDCs or plugs into DATATRAK to unify data capture, randomization, and trial operations.

What reporting capabilities does DATATRAK DTRK ePRO provide for clinical trial teams?

The solution offers unified reporting spanning eDiaries and EDC casebooks for combined compliance and clinical metrics. According to the company, teams can build integrated reports to detect signals earlier and streamline data review preparation.

Where are DATATRAK Powered by Fountayn databases hosted for studies using DTRK ePRO?

Databases are hosted in the United States, Japan, and Europe, with options for additional local hosting. According to the company, this supports global studies while aligning with regional data privacy and security requirements.