TECH OUTLOOKOctober - 20189suitability, data privacy and security, and regulatory acceptance. The collection of data on the patient needs to be as seamless as possible with minimal actions required from the patient. Another important aspect for increasing patient engagement is through selection of a low-burden device that is simple to use with an attractive form factor. It is recommended that devices should--where possible--support both iOS and Android operating systems to allow for a successful BYOD model. A single study app, which acts as the interface between the individual and the trial and includes features to support the patient in his/her day-to-day life, is also recommended. Compliance monitoring can be a significant contributor to the success of mHealth trials. Using technology to proactively flag non-compliance and utilize a multi-faceted approach to engage with patients--from app to SMS notifications to direct contacts contacting patients--can help drive greater compliance and ensure optimal data generation and capture. As with all technologies which collected personal data it needs to be done in accordance with GDPR requirements.The Best Approachto Identify the Right Partnership/Solution Provider New providers with new capabilities appear on the market almost every month, so selecting the right device is a challenging task and poses a number of critical questions; how to evaluate? Should we use single or multiple devices? Medical grade devices or consumer technology? Unfortunately, there are no simple answers, and certainly, there is no one device that can be used in all clinical trials. Of primary importance is the selection of a device that can generate the data required to meet the study needs. The device itself must have high usability, i.e., a good battery life, and must facilitate the collection and transfer of the required data. The trial design will also inform the device(s) selection process; if a device is being selected to support an endpoint, ensuring there is sufficient scientific evidence to support the use of that device is critical.Upcoming disruptions within Pharma Compliance spaceIt is evident that data is meaningless without context. In order to turn data into information and actionable insights, data analytics forms an imperative piece of the puzzle. As was described in a press release earlier this year, ICON is doing some very interesting work on the use of the Intel Pharma Analytics Platform. In this engagement we are evaluating the data from a number of sensor devices, all at the same time. We are looking for correlations across these data, which previously may have notbeenconsidered in order to generate new insights that have the potential to be clinically relevant.The potential to generate new insights from continuous measures captured--as patients go about their real-life--is significant. This is similar to motor vehicles using camera and recording technologies to monitor driver behavior, and customize insurance plans. The use of mHealth technologies will provide the opportunity for patients to more proactively monitor their disease and conditions in a way that wasn't possible heretofore.Advice for Budding Entrepreneurs Leaders must provide the evidence of where they have overcome challenges with their devices. It is also crucial to maintain early engagements with the regulatorspossessing roadmaps and recommendations. These recommendations play an important role as references when considering the incorporation of latest technologies in trial designs. Compliance monitoring can be a significant contributor to the success of mHealth trialsThomas N O'Lleary
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