Europe’s IMI adopts CDISC standards for research projects

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmaceutical industry, Pharmacology

Europe’s IMI adopts CDISC standards for research projects
Europe’s Innovative Medicines Initiative (IMI) has adopted the Clinical Data Interchange Standards Consortium’s (CDISC) standards for all future projects in a move announced this week.

Under the new agreement with CDISC, the IMI – a €2bn (€2bn) EU and the European Federation of Pharmaceutical Industries and Associations (EFPIA) organisation designed to promote safe drug development – will provide educational support and reference materials for the data standards to members.

The deal will also grant CDISC membership and access to the CDISC Members Only Area and portals to all academic institutions, small and medium-sized enterprises and other organisations receiving IMI funding.

Ann Martin, Principal Scientific Manager for Knowledge Management at IMI said: “To effectively manage information across a variety of projects requires a common format at the elemental level.

Our stakeholders felt strongly that it is good practice to adopt data standards. CDISC already provides such standards enjoying wide adoption in the pharmaceutical industry. The CDISC standards therefore could be considered as a default standard for research conducted through the IMI projects​.”

IMI member projects range from finding new biomarkers to educating researchers and using electronic health records for various research purposes.

CDISC’s standards – which are widelyused​ in the contract research sector - are consensus-based data formats that provide a common ‘language’ for data exchange during protocol design, data analysis and reporting.

CEO Rebecca Kush said: “CDISC is extremely pleased to formalise this relationship with IMI,” adding that “We have thoroughly enjoyed working with IMI to date, and we feel that this will be an invaluable mutually beneficial partnership that can generate standards-based innovations to streamline the development of new therapies and medical knowledge that will benefit patients worldwide​.”

Related topics: Clinical Development, Data management

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