CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.
CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.
|
