NAMs have the potential to deliver more efficient safety assessments, enabling faster and more confident development decisions while also supporting more ethical drug development.
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.
Every breakthrough begins with a single molecule. Follow the journey from early research to regulatory submission and learn how Instem helps teams work more efficiently, reduce risk, and deliver safer, more effective therapies to patients...
This white paper explains the fundamentals of quality assurance and why strong QA systems are essential for maintaining data integrity, compliance, and operational excellence in modern laboratory environments.
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™...
