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Enhacing TRANslational SAFEty Assessment through Integrative Knowledge Management

Objective

Drug safety assessment is a knowledge-intensive process that demands advancement in data handling methods and tools for facilitating data sharing, mining, analysis and predictive modelling. This need is not restricted to any specific type of data and real advancement requires integrating information of different types and from different sources (e.g. publicly available biomedical knowledge, proprietary preclinical and clinical data, evidence from post-marketing studies) for addressing drug safety assessment from a holistic perspective.

The eTRANSAFE project will address these needs by developing a powerful data integration infrastructure (Knowledge Hub) and a collection of computational tools (exploitation modules) for making optimal use of these data. The proposed system will be a flexible and expandable framework, built on previous experience and applying state-of-the-art methods and technologies for providing the most advanced solutions for data sharing, interoperability and exploitation. An experienced honest broker will guarantee the confidentiality of any proprietary data. The project will develop in silico tools for data mining, visualisation, and prediction of potential toxicity, with specific attention to the assessment of the preclinical to clinical predictivity and the discovery of safety biomarkers. The CDISC-SEND format will be supported, facilitating the preparation of regulatory-compliant documentation. This infrastructure will be underpinned by development of open standards and guidelines recognised by regulatory agencies and international organisations.

The eTRANSAFE consortium brings together 13 organizations that mobilize an unprecedented capacity and resources, uniquely placed to leverage the experience of eTOX and other EU projects and initiatives. The project partners are six prestigious academic institutions, six highly skilled small-medium enterprises (SME) and one European infrastructure (ELIXIR), bringing in this way a perfect balance.

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: The European Science Vocabulary.

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Keywords

Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)

Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

RIA - Research and Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-JTI-IMI2-2016-09-two-stage

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Coordinator

FUNDACIO INSTITUT HOSPITAL DEL MAR D INVESTIGACIONS MEDIQUES
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 884 759,00
Address
Doctor Aiguader 88
08003 Barcelona
Spain

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 884 759,00

Participants (31)

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