What is CDISC?
The CDISC (Clinical Data Interchange Standards Consortium) started in 1997 as a special interest group and was formally established as a non-profit organisation in 2000. The CDISC initiative has had great momentum in the past few years. Today more than 200 organisations in the pharmaceutical and biotech business, CRO’s, vendors of technology, academic institutions, and authorities back up this initiative as members of the consortium.
"The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare"
Regulatory implications
A uniform data format like CDISC eases the evaluation of regulatory files for marketing authorisations. An essential driver for CDISC is an endorsement from the FDA, which has now formally announced that the preferred data standard to be used in New Drug Applications is CDISC. The EMEA has not affirmatively endorsed one data standardisation system over the other, however, in general the idea and benefits of data standardisation are acknowledged also in Europe.
Benefits from CDISC
The CDISC initiative aims for global standardisation of storage and exchange of clinical trial data. This will improve and optimise work flows for all companies working with clinical trial documentation. It is effective and quality assurance is implicit. CDISC data standardisation establishes overview as well as insight into current and previous clinical trials. The CDISC uniform format enables comparisons across trials.
