Drug discovery and development is a knowledge-intensive process that clearly can benefit from integrative analysis of data from different types and that are produced by diverse organisations. These integrative approaches can facilitate decision making across the drug discovery and development pipeline, improving lead optimisation and enhancing risk assessment. A pre-requisite for this is the availability of representative and high quality datasets. However, to maximally leverage these data, important challenges such as encouraging information sharing among competing organisations, or promoting adequate data quality control, standardisation and annotation are required.The eTRANSAFE project will develop a data integration infrastructure and innovative computational methods that aims to dramatically improve the feasibility and reliability of data-driven translational safety assessment at all stages of the drug development process. This infrastructure will be underpinned by development of open standards and robust policies that are recognised by regulatory agencies and transnational organisations. Based on previous experience, the eTRANSAFE project proposes a state-of-the-art, powerful and flexible technical architecture for the data sharing, integration and exploitation. Key elements of this architecture are the specialised SEND data management system, the proprietary database managed by the honest broker, the knowledge hub, and the data exploitation modules . The eTRANSAFE consortium brings together 26 organisations that mobilise an unprecedented capacity and resources and that are uniquely placed to leverage the experience of eTOX and other relevant EU projects and networks. The project partners are eight prestigious academic institutions, six highly skilled small-medium enterprises (SME), eleven pharmaceutical companies and one Partner in Research.