This white paper explores how SEND-aligned data management is enabling the development of virtual control groups (VCGs), a transformative approach with the potential to significantly reduce animal use in preclinical drug safety studies.
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.
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.
