27 May 2015: Exco InTouch, the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, is pleased to be taking a strong lead in the advancement of clinical research through device integration.
Chris Watson, Product Manager at Exco InTouch commented: “Healthcare and clinical research is a field where undoubtedly the advance of technology has made a very strong mark. The very future of the industry is reliant on advanced and ever-more intelligent solutions that increase the cost-effectiveness of clinical trials through ensuring on-time and highly accurate recording of patient outcomes.
Designing solutions that are fully compatible with a multitude of home monitoring devices, capable of being integrated into eDiaries, via Near Field Communication or Bluetooth® have emerged as a strong market trend. The combination of the increasing use of ePRO data collection, combined with Bluetooth® technology being built into many devices, is fast enabling the integration of medical device readings into regular ePRO collection by patients, both in clinical trials and in healthcare settings.
Device integration goes way beyond just medical devices. There is a growing market, fast evolving, to utilize and integrate consumer technology that ranges from activity trackers (e.g. Microsoft Band or FitBit), to thermometers and weighing scales as tools to collect secondary outcomes data. Whilst class I or above medical devices are recommended for primary endpoints, especially in phase IIIa studies, a broad range of medical and consumer technologies are now finding application in secondary endpoints across all phases. This is due to the valuable insight such technology provides into physiological data and patient well-being.
There are multiple benefits to device integration. This includes ease of use for patients where real-time data review reduces the need for a visit to their HCPs or clinical sites, as well as time and cost savings in large projects. Furthermore, device integration resolves the problem of patients reporting incorrect information on their well-being, often a huge issue in real world evidence collection in clinical research and healthcare. Sponsors and healthcare providers now have technology at their disposal that provides them with access to real time result reporting whilst, at the same time patients are able to complete assessments using devices that form an integrated part of their lifestyle, through a simple, easily-recognizable interface.
Device integration brings with it a plethora of regulatory challenges. As a consequence, it is essential to define the use of the endpoint data and understand the regions in which it will be used. Regulatory authorities recognize different classes of medical devices based on their characteristics when in use, their design complexity and their potential to harm patients if misused. It is important to note that the use of devices for the collection of primary endpoints in Phase IIIa studies requires the devices themselves to be fully validated and checked. It is imperative that they ensure acceptable measuring tolerances that can be reproduced. In the European Union, for example, this means that, as a minimum, the device must be registered as a Class I measuring device, whereas in the US a device must have 510(K) registration awarded by the FDA to comply with the regulatory guidelines.
Device integration has proved its worth as a user friendly asset that can improve the accuracy, reliability and quality of patient data and reported outcomes. Allied to this, a clear market trend is evolving to design solutions fully compatible with a multitude of wearable and home monitoring devices, capable of reporting highly accurate recordings of outcomes. As a consequence, demand for device integration is rising fast.
About Exco InTouch
Exco InTouch is the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers. Using a combination of software and services, Exco InTouch solutions provide simple, secure channels of communication; facilitating the collection of quality data and improving outcomes for sponsors, clinical research organizations, sites and patients.
Working across clinical and late phase trials and mHealth programs, Exco InTouch’s device inclusive approach enables involvement which integrates into daily life - resulting in motivated and compliant patients, reducing costs associated with withdrawals from trials and improving overall program results.
Since 2004, Exco InTouch has engaged with over 1 million patients across 97 countries, over 26,000 hospitals and clinics, in 70 languages. 16 of the top 20 pharmaceutical companies have deployed our trusted applications in the knowledge that data is secure and protected, in line with global regulatory and data protection requirements.
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com
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Chris Watson, Product Manager at Exco InTouch commented: “Healthcare and clinical research is a field where undoubtedly the advance of technology has made a very strong mark. The very future of the industry is reliant on advanced and ever-more intelligent solutions that increase the cost-effectiveness of clinical trials through ensuring on-time and highly accurate recording of patient outcomes.
Designing solutions that are fully compatible with a multitude of home monitoring devices, capable of being integrated into eDiaries, via Near Field Communication or Bluetooth® have emerged as a strong market trend. The combination of the increasing use of ePRO data collection, combined with Bluetooth® technology being built into many devices, is fast enabling the integration of medical device readings into regular ePRO collection by patients, both in clinical trials and in healthcare settings.
Device integration goes way beyond just medical devices. There is a growing market, fast evolving, to utilize and integrate consumer technology that ranges from activity trackers (e.g. Microsoft Band or FitBit), to thermometers and weighing scales as tools to collect secondary outcomes data. Whilst class I or above medical devices are recommended for primary endpoints, especially in phase IIIa studies, a broad range of medical and consumer technologies are now finding application in secondary endpoints across all phases. This is due to the valuable insight such technology provides into physiological data and patient well-being.
There are multiple benefits to device integration. This includes ease of use for patients where real-time data review reduces the need for a visit to their HCPs or clinical sites, as well as time and cost savings in large projects. Furthermore, device integration resolves the problem of patients reporting incorrect information on their well-being, often a huge issue in real world evidence collection in clinical research and healthcare. Sponsors and healthcare providers now have technology at their disposal that provides them with access to real time result reporting whilst, at the same time patients are able to complete assessments using devices that form an integrated part of their lifestyle, through a simple, easily-recognizable interface.
Device integration brings with it a plethora of regulatory challenges. As a consequence, it is essential to define the use of the endpoint data and understand the regions in which it will be used. Regulatory authorities recognize different classes of medical devices based on their characteristics when in use, their design complexity and their potential to harm patients if misused. It is important to note that the use of devices for the collection of primary endpoints in Phase IIIa studies requires the devices themselves to be fully validated and checked. It is imperative that they ensure acceptable measuring tolerances that can be reproduced. In the European Union, for example, this means that, as a minimum, the device must be registered as a Class I measuring device, whereas in the US a device must have 510(K) registration awarded by the FDA to comply with the regulatory guidelines.
Device integration has proved its worth as a user friendly asset that can improve the accuracy, reliability and quality of patient data and reported outcomes. Allied to this, a clear market trend is evolving to design solutions fully compatible with a multitude of wearable and home monitoring devices, capable of reporting highly accurate recordings of outcomes. As a consequence, demand for device integration is rising fast.
About Exco InTouch
Exco InTouch is the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers. Using a combination of software and services, Exco InTouch solutions provide simple, secure channels of communication; facilitating the collection of quality data and improving outcomes for sponsors, clinical research organizations, sites and patients.
Working across clinical and late phase trials and mHealth programs, Exco InTouch’s device inclusive approach enables involvement which integrates into daily life - resulting in motivated and compliant patients, reducing costs associated with withdrawals from trials and improving overall program results.
Since 2004, Exco InTouch has engaged with over 1 million patients across 97 countries, over 26,000 hospitals and clinics, in 70 languages. 16 of the top 20 pharmaceutical companies have deployed our trusted applications in the knowledge that data is secure and protected, in line with global regulatory and data protection requirements.
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com
Help employers find you! Check out all the jobs and post your resume.
