ePRO
ePRO solutions increase data quality
We offer a comprehensive portfolio of ePRO solutions from which we select and configure the right product for each study together with you. Thereby we use an intuitive, simple, and clear design of the applications in compliance with the FDA guidelines.
ePRO (electronic patient reported outcomes) or eCOA (electronic clinical outcomes assessment) are data that are documented directly by the participants and that describe their personal well-being. They are recorded using so-called quality of life questionnaires or diaries.
The well-being of the participant is coming more and more into the focus of sponsors and thus frequently serves as a primary or secondary endpoint of clinical trials. Using ePRO solutions has many advantages over capturing PRO data on paper. On the one hand, the labor-intensive and error-prone process of transferring paper to a database is eliminated. On the other hand, the participant’s compliance is higher due to targeted reminders, to support entering data regularly and on time. In addition, answering the questions on a device is perceived as a more private situation compared to answering questionnaires on paper as the completed questionnaires are not handed out to the attending staff, but sent to the database directly. Overall, the use of ePRO solutions increases the data quality enormously.
ePRO direct access: Data is recorded by the patient directly in the eCRF
Our ePRO browser application enables patients to directly access the eCRF via any browser with a straightforward graphical user interface. The extension introduces full flexibility with the possibility to assign groups of patients to different questionnaire sequences and to show sets of questions only for specific reporting time points. The data manager is enabled to overview patient’s progress and to manage patient’s access to the questionnaires.
The mobile app LinkPRO: workflow for the participants
The app LinkPRO is a native app that is installed on a mobile device (smartphone or tablet). It is available to the participant through the Android and iOS app stores. Participants register by entering the study data and their personal user credentials. The participant can configurate the app and start documentation. The documentation can be done online or offline, the data is stored encrypted on the device. Once internet access has been established, the stored data is automatically sent to the eCRF. If it becomes necessary to change a questionnaire or a diary due to an amendment, this is possible without any action required from the participant. The configuration is checked regularly and updated, if necessary, as soon as internet access is available.
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