FREQUENTLY ASKED QUESTIONS - ePRO (mobilePRO) SERVICES

Exco InTouch’s mobile ePRO solutions are delivered on the most ubiquitous communication technology in the world, the cell phone. With over 5 billion mobile / cell phones in use globally and 70% of the world’s population now owning a cell phone, Exco InTouch has successfully harnessed the power of the mobile phone for use in clinical trials and healthcare programs. Nobody goes anywhere without their wallet, car keys and cell phone which ensures that this technology solution enjoys unrivalled adoption in the patient population. The additional advantages of mobilePRO are:

• There are no hardware costs

• No complex devices to manage, buy, ship, import/export then repatriate and store

• It is fast to deploy, requiring minimal sponsor involvement / time

• Cell phones are always on, charged, available and ready to go, reducing the site preparation and training burden

• Patients already know how to use their own mobile phone. Using mobile ePRO is as easy as reading and responding to a text message 

• Transmission of data occurs automatically after each questionnaire is completed without the need to place devices in cradles or sleds. Therefore ensuing that data is sent to the study team minutes after data entry rather than hours later or not at all!

How do you ensure that the diary / assessment is validated across all mobile phones used? 
As part of our design and build process we test the applications across a number of platforms. Where there is an issue we will provision the phones for the study on which the system has been validated. Due to the minimal hardware costs this is significantly cheaper than commissioning a handheld PDA-style device.

In accordance with FDA 21 CFR Part 11 regulatory requirements, all patient self-report data is digitally signed by the patient by the use of a unique, user generated Personal Identification Number (PIN).  Patients must enter their PIN via 2-way SMS message to confirm their identity before they can begin completing their diary entries. Therefore if a phone is lost, the diary cannot be completed by a third party.  Additionally, all Exco InTouch IT systems and processes have been architected to comply with HIPAA regulations. Security is inherent within all applications with a full audit trail of all communication messages including date and time stamps which record delivery and receipt data.

YES, both ePRO CELL and ePRO APP can be deployed for use at clinical sites. We recommend the use of ePRO APP provided on large screen smart phones or data-enabled tablets which are ideal for patients to use during a site visit to complete their outcome data. ePRO APP is a user friendly java application that runs on the cell phone. Exco InTouch provision suitable devices to sites with the java technology pre-installed, data is relayed to the Exco server in real time unless there is no connectivity available, in which case the application will work offline and re-connect and transmit data when signal is resumed.

Our ePRO SMS solution is PIN protected to comply with 21 CFR Part 11 regulations. Patients must enter their PIN number via 2-way SMS message to confirm their identity before they can begin completing their diary entries. Therefore if a phone is lost, the diary cannot be completed by a third party.

Exco InTouch also maintain a buffer stock of devices and can deploy them to sites / patients very quickly when required We also ensure there is a mechanism in place to replace lost or stolen handsets with minimum disruption to the patient and study.

As long as the phone has a browser and a data connection it can be used the ePRO CELL or ePRO  APP solution.

In ePRO CELL each browser may display the application slightly differently.  We test using a wide variety of phones to ensure the general look and feel is the same on the majority of phones. Where a possible problem is identified we are able to provision phones for the individuals affected.

ePRO APP has all the functionality associated with ePRO CELL but as a downloadable application it is also deployable on PDA’s, Tablets and PC’s. As a locally installed application continuous connectivity is not required to collect the patient data ‘offline’ but it will require a connection to send the data.