CDISC and IMI Sign Standards Agreement

By Bio-IT World Staff    

December 20, 2011 | The Innovative Medicines Initiative Joint Undertaking (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients.     

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

The Clinical Data Interchange Standards Consortium (CDISC) has developed consensus-based data formats that provide a common global ‘language’ and enablers for obtaining, using and sharing information to enhance science and improve research and healthcare. The CDISC suite spans the research process from the study plan (protocol) through data analysis and reporting. CDISC also provides enablers for using electronic health records (EHRs) for     

research.    

The agreement between CDISC and IMI provides CDISC education and materials for IMI consortia members, as well as a CDISC membership and access to the CDISC Members Only Area and portals for all academic institutions, small and medium-sized enterprises and other organisations receiving IMI funding in IMI projects. The EFPIA partners involved in IMI projects are already CDISC members. IMI project teams will use CDISC formats and standards where applicable and, when not available, they will participate in developing new ones.     

The agreement was spearheaded by Ann Martin, Principal Scientific Manager for Knowledge Management at IMI. “To effectively manage information across a variety of projects requires a common format at the elemental level,” said Ms. Martin in a press release. “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.”     

“CDISC is extremely pleased to formalize this relationship with IMI,” said Rebecca Kush, president and CEO of CDISC in a press release. “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.” CDISC is also now a full participant in several IMI consortia through its CDISC Europe Foundation.     

This partnership will allow IMI and CDISC to further develop tools that will advance the development of better and safer treatments for patients.