The CDISC Europe Foundation supports a number of projects with European-based staff dedicating varying degrees of resource commitments, from serving in advisory roles to providing full-time engagement, depending on available budgets and strategic alignment with CDISC goals.
Biomarkers for Enhanced Vaccine Safety (BioVacSafe)
The BioVacSafe project aims at establishing 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 strives to accelerate developing, and introducing, a new generation of safer, more effective vaccines. BioVacSafe is 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 is putting 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.
European Translational Information & Knowledge Management Services (eTRIKS)
An Innovative Medicines Initiative (IMI) project funded to support other projects, eTRIKS is 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 has been leading the standards advisory team who has advised on a wide array of translational research projects, which eTRIKS supports, and has recently published the standards starter pack, which is in wide use within IMI.