1

Zero footprint – no loss of data
ViedocMe is a web-based, app-like cloud application. What that means is that the software is on the server – all that is required on the user’s device is a web browser that supports standard HTML. Once the user logs on to ViedocMe the application has the same look and feel as an App installed on the device – but without being installed. There is no software or data stored on the device, and if the user should lose or change devices it doesn’t affect the data collection in the slightest.

2

Logistics
The largest single expense in an ePRO/eCOA trial is the cost of purchasing, distributing, repairing, replacing and collecting the devices used. In addition the site and subject need support for these devices, meaning the ePRO/eCOA vendor must supply a helpdesk that is in direct contact with them. Helpdesk must be provided in all languages applicable for the study – even if the investigator might speak English there is no guarantee that the subjects can. Bring Your Own Device – BYOD – totally removes the device expense and the need for any direct contact between the vendor and the site or subject. The subject is using their own device, a device they are already familiar with. The zero footprint solution means there is no data stored on the subject’s device, and no data loss if their device should be lost, stolen or replaced.

3

Data instantly accessible and the eCRF is the source data
In a traditional ePRO/eCOA solution the data is stored in a separate database hosted by the ePRO/eCOA vendor. That database can either:

• be handled separately (i.e. all clinical research staff from the study nurse and investigator to the monitor and data manager get logins to that system as well as the EDC system), or
• the data can be transferred to the EDC database via synchronization, usually once a day (e.g. at midnight).

ViedocMe transmits the ePRO/eCOA data directly to the eCRF, with no secondary databases. The eCRF contains the source data – the first and only enduring storage of the data collected (as no data is stored locally on the devices). Hence, the source data are the data stored in the central database.

4

Data changes
Source data should be accurate, which means that a procedure should be in place to address the situation when a study subject realizes that he/she has made a mistake and wants to correct the submitted data. ViedocMe offers support for correcting ePRO data in a way that helps finding the optimal balance between data authenticity and data quality, while at the same time preserving data integrity. Such a balance is achieved by not allowing for excessive rethinking of answers by subjects, but instead providing a built-in threshold that serves as a filter for those changes that really lead to an improved accuracy of the data, and by recording all changes in an audit trail that is accessible for both investigators and sponsor users.

5

Easy setup
ViedocMe is configured and setup as part of the standard Viedoc study design, using the same tools and forms. When you set up a form in Viedoc you select if you want to post it to the subject or if it will be part of the regular CRF. This allows you to set up both the CRF and the subject questionnaires simultaneously, saving time and money. There is no need for additional training or special personnel to setup the ePRO part of your study.