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A fully compliant plug-and-play pipeline for clinical trial data

Life sciences clinical researchers now have access to a new digital tool: NNIT Clinical Study Accelerator (CSA). CSA makes it possible to transfer real-time data from IoT devices in a compliant and flexible way. This enables swift and secure data management in a GxP setting and significantly enhances the range of options in the data analytics.

 

When developing new products, pharmaceutical companies are looking to eliminate the need to gather patient information at physician or investigator sites. This is increasingly realized using digital communication and Internet of Things (IoT) devices.

This method both allows for a better patient experience, an increased number of data points and improved data quality, thus allowing the life sciences companies to achieve a faster time to market, lower cost of clinical trials and higher drug candidate success rate. But in order to gain these benefits, the companies must be able to collect, process and submit the IoT-data to the health authorities in a compliant manner.

Plug-and-play service

It is for this exact purpose that NNIT has developed the new digital service, which can be deployed on premise or as a cloud solution at the push of a button.

– "With the new service, we build a qualified digital pipeline that sends a stream of data from a device or sensor into the clinical data management systems. It is as close as you get to ’plug and play’ in pharma: A compliant infrastructure delivered as a service out of the box. On top of it – in order to tailor it to the needs of our clients – we also offer the advisory and implementation if needed", says Stefan Brügger, Senior Life Sciences Consultant at NNIT.

Backend is the main pain point

The new 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. This allowed the NNIT team to identify the most pressing pains in connection with incorporating IoT devices in clinical trials and adjust the solution accordingly.  

–  "We originally included the device selection and qualification as part of our services. But we learned from our collaboration with clients that they often have case by case methodologies in place for this. The handling and streaming of IoT data in a compliant way, however, was a much more pressing need. At the end of the day, the clients’ major pain points lie mostly with the qualified infrastructure at the backend", says Stefan Brügger.

Want to know more?

Visit https://www.nnit.com/Life-Sciences/Clinical-Development/Pages/IoT.aspx to find further information about how NNIT can help you bring innovation to your clinical trials.

Contact us today

To begin an immediate conversation about how NNIT can help you, please contact Stefan Brügger, Senior Life Science Consultant on +45 3077 9049 or SEFB@NNIT.COM


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.

 

Article written: December 2018

 

 

 

Stefan Brügger+45 3077 9049sefb@nnit.comManaging Consultant, Life Sciences Deliveryhttps://www.linkedin.com/in/stefan-br%C3%BCgger-6bb8498a/Stefan Brügger

 

 

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