It’s important to consider SEND guidelines throughout the process, not only before submission, to prevent costly surprises.
This session will discuss the opportunities for data use beyond submissions, specifically in the area of constructing virtual control groups.
While there are great open-source resources out there, in the nonclinical world, we prefer fully commercially available, supported, validated tools from trusted vendors in the space.
Implementing Protocol-Driven (Q)SAR Mutagenicity Assessments for Pharmaceutical Impurities.
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.
