The introduction of Internet of Things (IoT) in the form of devices in clinical trials has made it possible to collect large volumes of real-time patient data 24/7. At NNIT, a dedicated task force is working to provide life sciences data scientists with the tools to take full advantage of these unprecedented opportunities without compromising compliance and security.
The need for time-consuming and costly manual data collection in clinical trials is increasingly being replaced. Thanks to the introduction of portable IoT devices – which can be worn, ingested by or even implanted in patients – life sciences companies can collect real-time data 24/7, with the added benefit of higher patient retention, since this form of data collection is much more patient-centric.
Let’s take a specific example: An elderly woman is part of a clinical trial to qualify a new heart medication. This involves going to the hospital every other day for an ECG. Obviously, such frequent trips are a major disruption in her daily routine and social life. Instead, she would be provided with a connected device that could continuously measure her heart rhythm and create regular electrocardiograms around the clock. The device would stream the data to her mobile phone, which would again transfer it to a central data repository, where the stream could be surveilled and analyzed for alerts or data quality purposes.
The potential benefits that this technology can provide life sciences organizations is plain to see. But there are plenty of obstacles along the way. At NNIT, a dedicated task force of corporate entrepreneurs is currently working on ensuring that the data can be handled in a compliant and secure manner. All the way from the IoT device to the infrastructure of the life sciences organization.
The task force is currently in dialogue with six large life sciences organizations on the matter of live data transfer and data ingestion for clinical trials, getting a clear understanding of the priorities and pain points they encounter.
– The constant stream of real-time data from multiple devices can supply life sciences companies with huge amounts of highly reliable raw data in central depositories. This will enable data scientists to discover trends and make observations that were not previously possible, especially if we add artificial intelligence tools to the mix. And the same data can be used in the dialogue between patient and physician to provide valuable feedback. We are working to ensure that traceability, security and privacy are in place throughout the data handling life cycle, says Stefan Brügger, Senior Life Sciences Consultant at NNIT.
Top of mind with most of the life sciences organizations is to ensure that the open data stream from device to infrastructure is fully compliant with all relevant regulations and standards. The main technical complexity is to keep an uninterrupted flow of data compliant all the way to the ultimate destination, regardless of whether the data capture happens with a dedicated device such as a wearable sensor or through software as a medical device.
– Both regulators and life sciences companies are highly focused on having compliance keep up with technology. Agencies such as the FDA and the European Medical Association are already at work streamlining regulations and defining the criteria that these new solutions must live up to. The updated EU Medical Device Regulation, which will be mandatory from 2020, is an example of this. At NNIT, we’re obviously following this work closely, to ensure that all our solutions have full regulatory compliance, says Bjarne Wiboe, Compliance Expert at NNIT.
Click here to find further information about how NNIT can help you bring innovation to your clinical trials through IoT devices and Software as a Medical Device.
NNIT is an international consultancy and operator in the development, implementation, validation and operation of IT for the life sciences industry. A NNIT solution guarantees expert advisory services and a high-quality, unique product – tailored to your needs, and with a high level of data security.