1 February 2023 News

5 Ways to Implement ePRO (electronic Patient Reported Outcome) in Your Clinical Trials

ePRO (or eCOA – Electronic Clinical Outcome Assessment) is a software that allows patients to share information with investigators via their own electronic devices using a mobile or web application instead of paper forms.

Patients can submit various data in manual or automated mode, such as vital signs, general health state, medication regimen compliance, and inform doctors immediately about any side effects / adverse events.


ePRO shows great advantages over paper, with the most prominent one being the immediate access to patient’s data.

The study “WITH THE MULTITUDE OF BENEFITS THAT ePRO PROVIDES, WHY ARE CLINICAL TRIALS STILL USING PAPER?” by Elisa Holzbaur, BS & Jennifer Ross, MS, M.Phil.Ed, reports that 77% of patients prefer electronic diaries to paper forms.

Apart from just superseding paper diaries, ePRO definitely helps with the following:

1) Pharmacovigilance source data capture. Imagine that a patient, without even realizing that, develops symptoms that could progress to a serious condition – in such a case, a paper diary that is due for review in several days at best, imposes high risk to the patient’s safety.

ePRO handles such signals without delay by applying standard algorithms, neural networks and involving doctors into the case review. It wouldn't be an exaggeration to say that ePRO helps save lives of thousands by controlling life-threatening conditions in a timely manner.

2) Treatment compliance increase. ePRO can not only capture data submitted by patients but also regulate their behavior by reminding them of a due measurement, drug intake or scheduled visit. Statistics shows that patient involvement correlates directly with the clinical data quality.

3) Direct access to data captured with wearables. In classical research, any data from wearables would become available once the data collection is finished and the respective devices are handed over to the investigator or data manager for data extract, analysis and reporting.

With ePRO, any such device is integrated into the data management system, so it transmits data in the real time mode for instant consolidation and gaining all the associated benefits.

4) ePRO as a marketing tool. Why not use ePRO to capture not only clinical data from your patients, but also the actual information about their location, habits, behavior, and preferences? 

Reading the smartphone data automatically can bring you many times more information than just relying on what the subject inputs manually. 

Of course, you must assess all risks, comply with the ethical standards, and obtain the subject's consent throughout the entire data processing period.

5) A means to stimulate patients motivation and loyalty. Researchers report that when a clinical trial subjects feel ongoing care and support provided via an easy-to-use electronic system with built-in emergency contacts, health assessment and complaints handling tools, the subjects demonstrate real trust in the product quality and better loyalty to the maker.

We at Data Management 365 are happy to announce that our MainEDC™ ePRO solution offers all the above mentioned opportunities. 

Feel free to contact us and learn more about how to speed up and improve your clinical trials conduct, and protect your subjects safety.

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