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Disruptive Real World Data & Real World Evidence Internet of Things platform for faster and more accurate clinical studies

Project description

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Making clinical trials faster and more efficient

There is a way to reduce the increasing delays and rising costs of life-saving clinical trials. It is also possible to ensure that patients, doctors and other stakeholders receive the needed evidence to make real-world decisions. The EU-funded HumanITcare project is a disruptive Internet of things (IoT) platform that provides real world data and evidence. The platform can remotely monitor patients' symptoms in clinical trials. The overall aim of the HumanITcare project is to work towards entering the clinical market, with the main aim to improve patients' health outcomes. Patients and clinical researchers are the final users with whom the project has extensively worked on locally and at a European level.

Objective

Clinical trials (CT) take an average of 8 years and $100M to complete and is a key component in drug development. Relevant to this proposal, some of the reasons that cause CTs to have high costs and lengthy time frames for Study Sponsors are ineffective monitoring, poor quality control measures, poor data management and lack of reporting tools. Among all phases, on average, these challenges amount approximately the 45-50% of the costs. Furthermore, traditional methods for evaluating the evolution of the patient’s symptoms produce data that is episodic, subjective and scarce, meaning that patients, clinicians, and other stakeholders do not get the needed evidence for making real-world decisions.

We propose humanITcare, a disruptive Internet of Things (IoT) platform that provides Real World Data (RWD) & Real-World Evidence (RWE) which is innovative because provides a passive 24/7 remote monitoring of patient’s symptoms in CTs, validated in a clinical study with 60 participants in Hospital Clinic of Barcelona.

Patients and clinical researchers are the final users with whom we have extensively worked on locally and at a European level in product validation and market fit. In the first internationalization year, we plan to go to strategic EU countries (Belgium, Germany and Sweden).

We are a multidisciplinary team, including senior physicians, data scientists, software engineers as well as business and health experts. We have been awarded thrice from EIT Health. Our ambition is to be the best company for remotely monitoring the health of patients or the overall population using their own devices or disease-specific devices. With the grant and the coaching of the SME phase I, we intend to perform 1) market study; 2) regulatory analysis; 3) business plan. As part of our ambition, in 4 years, we will work towards entering the clinical market too with the aim to improve patients’ health outcomes by providing a better follow-up.

Fields of science (EuroSciVoc)

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.

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Programme(s)

Topic(s)

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

FOLLOWHEALTH SL
Net EU contribution
€ 50 000,00
Address
ARISTIDES MAILLOL 17 9 4
08028 Barcelona
Spain

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Yes
Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 71 429,00

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Last update: 17 August 2022

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Permalink: https://cordis.europa.eu/project/id/885173

European Union, 2025

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