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How to Power Clinical Trials with Internet of Things

How to Power Clinical Trials with IoT

How to Power Clinical Trials with Internet of Things

On July 16, Arithmos’ 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 Arithmos 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.

Would you like to learn how Arithmos can support you in innovating your clinical trials? Contact us by clicking here.

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Navigating Business in Times of COVID-19

Navigating Business in Times of COVID-19: Interview with Paolo Morelli

Navigating Business in Times of COVID-19: Interview with Paolo Morelli

COVID-19 pandemic forced companies to explore how to survive while ensuring business continuity and protecting the health of their employees. We talked to Paolo Morelli, CEO of PM Holding (Arithmos, CROS NT, seQure), in order to understand what business owners can do to mitigate the impact of the pandemic on their operations, ensure business continuity, and deliver better outcomes in times of crisis.

What were your initial steps when the outbreak started?

We had two major concerns when the outbreak started: safety of our team and business continuity.

In order to deal with these concerns, we have formed a risk management team and carried out an operational and commercial revision. The former was necessary to mitigate the risks for our clients and employees, while the latter allowed us to adjust the way our company interacts with the market.

The operational and commercial revision was a way to quickly reassess the situation from the business point of view. COVID-19 had changed the way our Life Science industry operates, so we needed to evaluate regulatory aspects of the new situation and understand new operational constraints. For example, we had to assess how to conduct GCP audits with travel restrictions or how to do on-site monitoring. All of these questions needed urgent answers if we wanted to continue delivering services to our clients.

How did the transition to the home office go?

Smoothly. In the last 5 years we have created a structure that allowed our teams to move to their home office without any obstacles. All the companies across PM Holding have a very clear organisational structure. Each company has a managing director, line managers, team leads that work closely with their units and have clear work objectives. We currently have in place recurring meetings and revisions to ensure that projects are delivered on time and many of our colleagues already have experience with working from home.

All these factors combined with the reliable IT infrastructure and underpinned by our company values – trust and communication – allowed us to switch to home office working in the blink of an eye.

What is the biggest challenge in managing a business in pandemic times?

I believe that regardless of the industry, the most challenging part is the change management. All of us are more comfortable with doing things in a familiar way and we can sometimes struggle when we need to adopt new paradigms as some are very risk adverse.

However, these are times when we need to be flexible and adopt a smart strategy effectively, like during the COVID-19 pandemic.

Paolo Morelli, CEOAre you happy about the way PM Holding companies are coping with the COVID-19 challenge?

Yes. We have worked hard to build the company culture based on trust, innovation, and communication and I see very clearly now that the results of these efforts and investments.

What have we learnt?

First of all, we now have proof that our processes and internal structure are really effective. In calm periods these processes, rules and procedures may seem unnecessary and too strict, but in times of crisis like COVID-19 pandemic, they turned out to be hugely advantageous. They have allowed us to provide business as usual approach to our clients and ensure smooth transition to the home office for our teams.

Secondly, we have seen the importance of glocal management. Thinking globally and acting locally allows us to have a global strategy and global mindset, and at the same time, consider local events and be as close to our clients and employees as possible.

How can businesses deliver better outcomes in times of a crisis?

There are three tips that I would like to share:

  1. Analyse the company organisation and understand the new risks
  2. Define the risk mitigation plan and do the necessary changes in the company organisation
  3. Identify opportunities that the crisis may give rise to

I also can’t emphasise enough the importance of innovation. Innovation needs to be part of company culture, as this is one of the only ways to find new solutions, take risks and cope with adverse circumstances successfully. I am not talking only about technology here – innovation is a mindset! We need to develop this mindset and bring the younger generation into our businesses, as they are like sponges and take onboard so much information, have open minds and are able to think outside the box.

What do you think will be COVID-19 impact on Life Sciences?

Pre-COVID-19 working from home in our industry was the exception rather than the rule, however, it may be vice versa in the future. I also think there will be much more focus on decentralised clinical trials and further enhancing technology with the buy in both from sponsors and patients.

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