Marc Ellison, Director, Regulatory Solutions, takes a closer look at the FDA feedback on the new CDISC standard: Dataset-JSON v1.1 as a replacement for XPT files.
Begin considering the systems that collect and report those data and how they may be connecting to your SEND tools. CROs will have far more data and study types that are now modelled in SEND.
There has been a lot of buzz around Dataset-JSON for a while now, and so, like any responsible vendor, we have been keeping a close eye on the development of the standard.
Read the latest from our Sensible SEND blog.
Read the latest blog from Marc Ellison, Director, SEND Solutions, Instem.
The ICH S1B guidance is making significant ripples across our industry, potentially saving years of effort in the development of a new drug, and SEND can play its part in enabling this.
