Non-GLP studies that support regulatory safety decisions are required by the FDA to be submitted in SEND, regardless of GLP status. Data collected in Climb™ can be efficiently converted into submission-ready SEND using Instem’s Submit™...
Outstanding client support is becoming increasingly critical across industries, and the life sciences sector is no exception. As innovation in research and development accelerates, providing clients with expert guidance throughout drug development, study management, and...
It’s important to consider SEND guidelines throughout the process, not only before submission, to prevent costly surprises.
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.
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.
