With the Federal Register notice on December 18, 2014 FDA finally mandating the use of CDISC standards for electronic submissions. This announcement was an important ‘next step’ for clinical systems.
Next Step was founded with the idea that the combining CDISC standards with technologies that enable fully automated, electronic clinical data interchange offers substantial improvements in efficiency, productivity and information availability to the clinical research enterprise. Greater information sharing serves to make the products of biomedical research available to patients sooner and more safely. Increased efficiency and productivity serves to manage and reduce costs.