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The CDISC Europe Foundation assists CDISC in meeting the needs of our Europe-based members by offering support and participation in projects and events taking place throughout the continent. The CDISC Europe Foundation qualifies as an EU Research Organization.

Fairshairing.org:  A curated, informative and educational resource on data and metadata standards, inter-related to databases and data policies.

 

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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.

With a €2 billion research fund, IMI supports collaborative projects through consortia comprising academic experts, small and medium-sized enterprises, patients’ organisations, pharmaceutical companies, and regulators to support innovation in research and development in Europe. IMI projects range from finding new biomarkers for the development of safer and more effective treatments for patients, to educating researchers and using electronic health records for various research purposes.

The IMI and CDISC are working together to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients.

IMI-funded organizations can receive a 20% discount off CDISC annual membership fees at either the Gold or Platinum Levels, allowing them to take advantage of discounts on CDISC training and events as well as additional membership benefits.

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.