Data can be entered both on a sponsor owned device as well as on a patient’s personal mobile device.
Remote data collection
Patients can enter data remotely into their own devices, without having to visit sites. The app is supported by over 90% of all the smartphones and tablets produced worldwide.
Patients can enter data even when they do not have the internet connection. All the input data is saved and synchronized with the cloud and then automatically uploaded to the EDC, once the connection is back on.
Automatic fonts and elements optimization for different devices. In-build designer for non-typical cases – figure of body or body parts, specific options for rare diseases, etc.
Automatic data back-up every 24 hours. It is not required for a patient to enter their personal data to access the app. All the information is encrypted and secured. Audit trail function keeps track of all the authorization activities and data edits.
In case of international multi-site clinical trials, patients can choose a local language for the app.
Sponsor’s info module
With this module sponsors can communicate pieces of advice and make suggestions on increasing the patients’ involvement or supply information on new studies and other news. If a sponsor’s message requires extra attention it will always be shown on the top.
Advanced patient’s experience
Patients do not need to memorize when they need to access the app or create reminders for that. The system will take care of it. All the notifications on filling out the questionnaires show up offline as well.
24/7 helpdesk and technical support
You can list a phone number and/or an email for a regional trial support both for a group of patients or a single patient. With the “Chat with an investigator” option, study subjects can address their investigators via chat box.
Advantages for sponsors
Cleaner data due to the reduced number of errors compared to paper diary forms since most of the answer fields are standardized (e.g. the system will not allow to enter blood pressure in percentage or heart rate with a 4-digit number)
Full and strict compliance with protocol due to an audit trail. The notification system does not leave any chance to enter incorrect or insufficient data.
Study budget cutting opportunities due to the reduced number of monitor hours and saving on printing and logistics costs.
Advantages for patients
There is no need for a patient to memorize when to access the application, since they will receive reminders sent by the app. Moreover, patients will receive notifications even offline.
Increased patient engagement and their interest toward a study. Patients consider themselves a part of a trial more acutely and, as a result, demonstrate more responsibility toward submitting the results.
Easy-to-use filtering options and diaries and questionnaires status facilitate the filling out process for a patient when using the app. Data is entered easily and does not take much time to find.
Advantages for investigators
Saving time and resources because there is no necessity to transfer investigator’s data from paper to eCRF anymore.
There is no need for investigators to check the data entered by patients due to the automated check, which also excludes the risk of losing data. Moreover, since there is no chance that data may not be filled out, an investigator does not have to spend time restoring it.
Easy-to-find and-process data. All the information is instantly available online.
Introducing ePRO helped us to cut the study budget by 4 times. Electronic devices tend to get cheaper over time. Even if we will not use the devices for further studies and eventually write them off, the electronic format of the diaries is a lot cheaper than paper case report forms considering the printing and mailing costs. Besides, one should always consider data loss risks when mailing paper reports.
Clinical Trials Manager
ePRO help to avoid the so called “parking lot effect”, a situation when patients hastily fill out the questionnaires right before their doctor appointments. Therefore, in the end we get high-quality lean data. Besides, there is a notable the cost-saving advantage when using an ePRO because of the reduced hours put in by a monitor