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ePRO/eCOA/eSource for Clinical Trials

Datatrak’s ePRO gives sponsors a stronger, more connected way to run patient-facing trial activity by linking directly to Datatrak’s EDC and RTSM systems. The built-in connection gives teams better oversight, cleaner data flow, and fewer limitations than standalone tools that rely on weaker system logic.

The only category our ePRO ranks below industry standard is cost. Datatrak’s ePRO helps expand patient enrollment, improve participation from underrepresented groups, and support more affordable access to care without forcing studies into bloated technology spend.

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Increase Patient Engagement & Retention

Harness the power of informative videos, questions to measure comprehension, diagrams, images and study retention.

Flexible Design Capabilities

Build forms the way your team sees fit and make set up a breeze with pre-built libraries of standard eCOA forms.

Ensure Accuracy

Reduce confusion and error by enforcing workflows through edit checks based on the protocol.

Natively Integrated with EDC, RTSM & More

Industry-Leading Innovation — 34 Years After Datatrak Pioneered EDC

Datatrak’s ePRO allows patients to participate remotely in your study using Datatrak’s decentralized clinical trial solution to gather data directly from the patient using any device, including iOS or Android. Whether your trial is hybrid or decentralized, simplify the capture of electronic patient reported outcomes from patients and sites, while enhancing the quality of data with Datatrak.

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Key Capabilities

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    Natively integrated with EDC, RTSM, eTMF, eConsent, and more

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    Affordable ePRO access for studies of all sizes and budgets

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    Supports iOS, Android, and any device for remote patient participation

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    Increases enrollment and participation from underrepresented groups

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    Meets DEI criteria throughout the trial lifecycle with Datatrak DCT

Integrated Solutions

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Electronic Data Capture (EDC)

A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.

Clinical Trial Management (CTMS)

Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.

Electronic Trial Master File (eTMF)

Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.

eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with acloud-based pharmacovigilance software platform built for compliance.

EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

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"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology terapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intiutive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. They system is easy to use, you can create customized forms, manage study participants, securly store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user frienidly, and site stasff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

Frequently Asked Questions

What is eCOA in clinical trials?

eCOA stands for electronic clinical outcome assessments, the digital methods used to capture how a patient feels, functions, or survives during a clinical trial. It includes patient-reported outcomes (ePRO), clinician-reported outcomes, and observer-reported outcomes. Datatrak’s ePRO software is directly linked to our powerful EDC and RTSM systems, giving study teams a far superior EDC “brain” behind every outcome captured.

What is the difference between ePRO, eCOA, and eSource?

ePRO (electronic patient reported outcomes) captures data directly from patients, typically about symptoms, quality of life, and adherence. eCOA is the broader category that includes ePRO alongside clinician and observer assessments. eSource refers to data captured directly in electronic form at the point of origin rather than transcribed from paper. Datatrak’s platform supports all three inside one natively integrated workflow.

What devices can patients use with Datatrak’s ePRO?

Patients can participate remotely using any device, including iOS and Android, through Datatrak’s decentralized clinical trial solution. Whether your trial is hybrid or decentralized, our ePRO simplifies the capture of electronic patient reported outcomes from patients and sites while enhancing data quality, and supports increased enrollment from underrepresented groups to meet DEI criteria throughout the trial lifecycle.

News & Insights

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