On July 16, CROS NT’s CEO Paolo Morelli has joined a complimentary webinar organised by Avenga, global IT and digital transformation company. This exclusive webinar was prepared for Pharmatech, Life Sciences, Pharmaceutical, Drug Discovery & Development and Healthcare companies and focused on how Internet of Things (IoT) transforms clinical trials.
In this blog we share some of the webinar highlights.
Continue reading to learn about how IoT is used to combine disparate data, improve clinical trials through higher patient retention and reduce trial spans.
Avenga (A): How does the introduction of IoT changed your perspective on the industry?
Paolo Morelli (PM): Nowadays a big variety of patient data including data coming from IoT devices and what I call process data (i.e. KPIs of clinical trial processes) is available. This data becomes more and more valuable for the industry and increases the demand for specialised service providers that are able to work with such big data volumes and harness their potential.
A: What are the key items one should focus on when integrating IoT in clinical trial?
PM: I would outline four key elements:
- Study team that includes a digital manager to support the integration of the technology in the design of the study and study tools
- Patient association to ensure that patients will have smooth experience with the new technology
- Senior Data Managers and Statisticians to cope with regulatory challenges related to data collection and stat methodology
- Privacy expert
A: When it comes to IoT, what is the difference between a CRO role and a pharmatech company role?
PM: CROs support pharmaceutical companies in conducting clinical trials with clinical and data services. However, most of the CROs are only starting to explore the world of IoT and learning how to integrate them in the traditional services.
On the other side, pharmatech companies have already a broad understanding of technological framework. Thus, they are able to support both pharmaceutical companies and CROs integrating new IT solutions in clinical trials.
A: How do sponsors see IoT in clinical trials?
PM: Sponsors see IoT as a big opportunity as they understand the value of the data that can be generated and used to support clinical evidence and safety of their products. This is valid not only for pharmaceutical and medical device companies, but also for organisations that conduct non-profit studies.
However, the tackling of the growing importance of IoT is also challenging, as a lot of industry players still do not possess necessary analytical and technical capacities.
A: Have you had to adjust the compliance framework as well as other SOPs for the IoT related projects that CROS NT has conducted so far?
PM: Not too much, as the processes are independent from the type of source data and its quantity.
A: What are the new skills that young professionals should add to their skillset to be relevant in this labour market?
PM: Analytical skills are becoming increasingly important for both data scientists and clinical researchers, as they will need to understand the massive amount of reports available in every clinical trial.
Digital managers will also become indispensable for the correct selection and integration of IoT tools in clinical trials processes.
A: What is the connection between big data and data science and IoT?
PM: Data scientists have an important role in bringing together the huge massive of data that arrives from IoT devices.
A: How do you think Covid-19 impacted use of IoT in clinical trials?
PM: I think there will be much more focus on decentralised clinical trials that involve IoT devices and further enhancing technology with the buying both from sponsors and patients.