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CEF Projects

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The Innovative Medicines Initiative (IMI) is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The IMI is the world’s largest public-private partnership initiative aiming to speed up the development of better and safer medicines.

Under the IMI CDISC has been funded by the following projects:

European Translational Information & Knowledge Management Services (eTRIKS)

An Innovative Medicines Initiative (IMI) project funded to support other projects, eTRIKS was a collaboration among 17 partners – each combining their strengths in developing a platform and services for data staging, exploration and use in translational research. The eTRIKS project has delivered an open, sustainable translational research informatics/knowledge management platform, based on the TransMart System and agreed standards, including CDISC standards. CDISC led the standards advisory team who advised on a wide array of translational research projects, which eTRIKS supports,and published the standards starter pack, which is in wide use within IMI.  

Biomarkers for Enhanced Vaccine Safety (BioVacSafe)

The BioVacSafe project aimed to establish tools, methods and guidelines for evaluating vaccine reactogenicity and enhancing immunosafety of novel vaccines. By coming up with novel ways to identify and better understand the mechanism of adverse reactions to vaccines at all stages of development, the BioVacSafe Project attempted to accelerate developing and introducing a new generation of safer, more effective vaccines. BioVacSafe was a public/private consortium of 19 partners involving three of Europe's leading vaccine producing companies, experts from major academic institutions, small and medium-size enterprises and non-governmental organizations, including CDISC. CDISC  put together a Vaccines Reactogenicity module for SDTM, advising consortium members on standards implementation, and working with Imperial University on a CDISC-conformant, data-harmonisation and data-loading system.

Electronic Health Records for Clinical Research (EH4CR)

EH4CR was one of the largest public-private partnerships, which aimed at providing adaptable, reusable and scalable solutions (tools and services) for reusing data from Electronic Health Record systems for Clinical Research. CDISC staff provided expertise on semantic interoperability. CDISC ODM forms served as the starting point for defining the common data elements (CDEs) needed for clinical research queries. Additionally, CDISC ODM files were mapped to CDISC SHARE CDEs, providing an extraction specification for SHARE CDEs.