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Innovate with the NNIT Clinical Study Accelerator

Internet of Things (IoT) and connected smart devices have the potential to improve clinical trials through higher patient retention and reduced trial spans. However, in order to gain these benefits, life sciences companies must be able to collect, process, and submit IoT data to the health authorities in a compliant manner. The NNIT Clinical Study Accelerator makes this possible.


 
 

IoT devices for clinical trials are wireless tools for gathering digital biomarkers from the study subjects. By using IoT devices to gather data, it is possible to obtain higher data quality while at the same time lowering costs. The benefits of using IoT devices include:

  • Faster data collection – Often, near real-time clinical data will be available for analysis.

  • Higher patient retention – IoT devices are usually easy for patients to use, have a minimal impact on their daily lives and can limit the need to visit a clinic or hospital for data monitoring.

  • Higher data quality – With IoT devices, measurements are conducted with minimal patient involvement, often 24 hours a day at very high frequency levels, increasing the data grid.

  • Larger sample sizes – Due to the unobtrusive nature of IoT devices and the fast and accurate data collection, it is much easier to gather a sufficiently large sample of data.   

  • Shorter trial span – With higher patient retention and more frequent data creation, the actual length of your clinical trials can be greatly shortened and thereby increase product time-to-market.

  • Near virtual trials – IoT devices support clinical trials becoming virtual with patient inclusion, subject monitoring and site visits becoming virtual with less physical and more virtual connection to the subject.

However, there are several important considerations to make before using IoT in clinical trials, such as regulatory compliance, security, and the integration of data and devices. With the NNIT Clinical Study Accelerator (CSA), it is possible to quickly set up a real-time data transfer from IoT devices in a compliant and flexible way. This enables swift and secure data management in a GxP setting.

Plug-and-play service

With CSA you can collect, process, and submit IoT-data to the health authorities in a compliant manner. CSA can be deployed on-premises or as a cloud solution at the push of a button.

CSA is a quick integration allowing for the very fast adoption of IoT devices. You will get a qualified digital pipeline that permits streaming in clinical trials from a device or sensor directly to the clinical data management systems or to a built-in monitoring mechanism. It is as close as you can get to ‘plug and play’ in pharma: A compliant infrastructure delivered as a service out of the box. On top of that – in order to tailor it to your needs – we also offer advisory and implementation, if needed.

CSA is developed in cooperation with pharma companies

The NNIT Clinical Study Accelerator has been developed in an internal corporate entrepreneurial setting, in close cooperation with contacts on all levels of several major pharma companies and cloud vendors. This enabled the NNIT team to identify the most pressing pains when incorporating IoT devices in clinical trials and adjust the solution accordingly. During this process, we learned from our collaboration with clients that the handling and streaming of IoT data in a compliant way was a pressing need. Therefore, CSA is developed to bridge the gap and allow for quick adaption using validated infrastructure in the backend.

What are IoT devices for clinical trials?

Internet of Things in health care and clinical trials involves physical devices, such as watches and wearable sensors, specifically designed to record and process biomarkers. IoT devices in clinical trials permit the trial subject to go about their day while streaming digital biomarkers like heart rate, blood sugar, blood pressure and many other measurements.

Closely related is Software as a Medical Device – apps and programs that allow smartphones and smartwatches to collect biological data in an accurate and compliant manner. Since the data is electronically captured, it can easily be streamed through CSA as well.
What you need to consider before including IoT devices in clinical trials
While providing many benefits, using IoT in clinical trials is not straight forward. As a clinical trial manager, you need to consider:

  • The nature of the study – is it a screening trial, a diagnosis trial, or a treatment trial? The trial design affects the compliance process and technical requirements.

  • What data you wish to gather – a full overview of the desired data and level of data quality is important when screening to select the right type of device. 

  • Your digital setup – are you fully equipped to receive, process, and safely store the collected data? Consult your Technology Officer or IT Manager if in doubt.

 


An NNIT solution guarantees expert advisory services and a high-quality, unique product – tailored to your needs and with a high level of data security. We offer regulation-compliant IT solutions to the life science industry, including platforms to store and analyze patient data.

Book a meeting with one of our specialists

 


 

 

 

 

NNIT Life Sciences+45 7024 4242nnitcontact@nnit.com ​​https://www.linkedin.com/company/nnit-it-for-life-sciences?trk=company_nameNNIT Life Sciences

 

 

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