“For the first time, the FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. Just a clear statement that quality matters, and that poor SEND has...
Complete, Compliant, and SEND‑Ready Submissions for Regulatory Success
SEND Implementation Guide v4.0 is the biggest change I’ve seen to the standard in the 15 years I’ve been involved. Here’s what you need to know.
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...
