ePRO

The use of electronic diaries is supported by scientific research that shows memory recall of an event is often unreliable and laden with inaccuracies, further supporting the use of ePRO (Electronic Patient Reported Outcomes) versus traditional paper diaries.

In 2016 Smooth Drug Development team designed electronic diaries to engage patients to submit time sensitive health information while they go about their daily routines.

ePRO has huge advantages over paper questionnaires:

Feature	ePRO	Paper diary
Diary completion reminder	✔	✖
Data verification (automatic edit checks)	✔	✖
Control over data entry time interval	✔	✖
Availability of necessary questionnaires during corresponding study visits	✔	✖
Control over retrospective completion of the diary	✔	✖
Control over skipped items	✔	✖
Availability of data in real time to vital compliance information	✔	✖
Constant data archiving on the central server	✔	✖
Track changes and accurate timestamps	✔	✖
Privacy	✔	✖
Automatic data merge with Clinical Study Database	✔	✖

Smooth uses specially designed Tablet or Mobile phone devices for instant data capture and transfer to a centralized data center.

Smooth ePRO features include:

User friendly
BYOD (bring your own device) or given devices depending on project features
Automatic data transfer to the study site
Easy to use navigation screens
Secure – SSL Encrypted Communication
Controlled by central management servers
No data stored on the device itself
Instant access to eDiary data

We have successfully performed multiple clinical trials using ePRO. It enabled us to collect data from hundreds of patients in a short period of time and make objective assessment.

ePRO enables us to conduct smaller and what is more important conclusive studies due to a smaller variance of data from e-diaries.

Studies with ePRO may result in smaller budget, smaller patient population and possibility to have adaptive trial designs due to up-to-the-minute ePRO data.