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
- medical and health sciencesbasic medicinepharmacology and pharmacydrug safety
- natural sciencescomputer and information sciencesknowledge engineeringontology
- natural sciencescomputer and information sciencesdata sciencebig data
- natural sciencescomputer and information sciencesdata sciencedata mining
- natural sciencescomputer and information sciencessoftwaresoftware development
Programme(s)
Funding Scheme
IMI2-RIA - Research and Innovation actionCoordinator
08003 Barcelona
Spain
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Participants (31)
28006 Madrid
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
LS11 5PS Leeds
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69117 Heidelberg
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
2800 Kongens Lyngby
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
08034 Barcelona
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3015 GD Rotterdam
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2311 EZ Leiden
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1010 Wien
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EC2Y 5EB London
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90411 Nurnberg
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
CB25 9PB Cambridge
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
L3 5UX Liverpool
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80686 Munchen
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LE2 2LF Leicester
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
08002 Barcelona
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4056 Basel
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51373 Leverkusen
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65929 Frankfurt Am Main
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4070 Basel
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64293 Darmstadt
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2340 Beerse
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92284 Courbevoie
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60064 North Chicago Il
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151 85 Sodertaelje
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55218 Ingelheim
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Participation ended
EC1N 8JS London
91940 Les Ulis
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112 88 Bunkyo Ku Tokyo
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28760 Tres Cantos Madrid
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08018 Barcelona
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
67063 Ludwigshafen Am Rhein
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