IMI2 H2020 FACILITATE project grant
- Services:
- HEALTH
- CLINICAL TRIALS
- DATA
- ETHICS
FACILITATE is a project built on a patient-centered, data-driven, technological platform where dynamic consent allows the returning of clinical trial data to study participants within a GDPR compliant and approved ethical framework. FACILITATE starts off by providing clear rules in a trusted ethical, legal, and regulatory ecosystem before engaging patients as data generators.
This avoids the current situation where clinical data are siloed in separate repositories without any possibility to be used beyond their original single-sided purpose. FACILITATE will provide the technological solutions to comply with GDPR in medical research by building on the empowered stakeholders willingness to share and re-use their data.
The FACILITATE Consortium
The FACILITATE Consortium was constituted by drawing from a broad range of capacities to tackle the ambitious challenges related to future clinical trials, such as preventive, long-term, and real-world evidence trials. The Consortium took an innovative approach to the data return to study participants by asking them what they needed to be implemented to feel in a trusted ecosystem.
This required all Consortium participants to leverage on their existing networks to bring together stakeholders at all levels in the decision-making chain, including patients, healthcare professionals, software designers, clinical trials repositories processors and controllers, ethicists, lawyers, and other active regulators. Having obtained a dynamic consent on the data portability FACILITATE will re-use and cross-reference them with those contained in other repositories including RWE data captured across multiple settings and devices.
The duration of the project and the strategy
FACILITATE will last 4 years and will participate in the extended Pilot on Open Research Data of Horizon 2020. Its strategy represents a unique and innovative opportunity for developing a process for returning data pack to the study participants, and to evaluate the effectiveness of developer interoperability tools in the healthcare ecosystem.
Zentrix role in the project
Zentrix is a leading architecture and technical requirements work, including API specification. In scope of the FACILITATE project, Zentrix development will focus on the data sharing protocols, consent definition and federated platform development.
Zentrix will participate in integration and evaluation of the platform with the stakeholders, making the project outcomes and the process of returning data to the patients validated with the key stakeholders including patients. Zentrix develops the FACILITATE Website, dissemination material and assets required for the successful dissemination. The exploitation of the developed tools will be examined with the stakeholders with the possibility for commercialisation.
Zentrix Lab has participated in consortium building and drafting phase as one of the three technical partners gathered under the idea to develop interoperable infrastructure based on the outcomes of harmonization of the planned legal and ethical research.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101034366. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
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- HEALTH
- STAKEHOLDERS
- DATA
- ETHICS
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