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.
Instem is a contributing partner in the VICT3R Consortium, a collaborative initiative exploring the use of Virtual Control Groups (VCGs) in toxicology studies.
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.
Adapting to these changes can be challenging, but early adoption and thoughtful implementation lead to improved research efficiency.
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.
This presentation discusses next-generation study management solutions designed to solve industry challenges highlighted by our collaborators and users.
