Instem

On October 10, 2026, experts from Instem will join industry and academic specialists from across India in Pune to discuss the future of toxicologic pathology and preclinical research. The workshop will combine expert-led talks with networking opportunitie

SEND v4.0 represents one of the most significant changes to the Standard for Exchange of Nonclinical Data (SEND) in years. In the recent webinar, "SEND v4.0 Readiness Starts at Data Collection", Instem's Marc Ellison, Director of Product - Regulatory Solu

The hidden cost of PC-SAS, fragmentation, and manual validation that drains biostats and IT teams. Your statistical computing environment (SCE) isn't broken. Your team is still getting analysis done. But every quarter that passes, maintaining it costs mor

SEND v4.0 is the most significant expansion of the standard since version 3.0, introducing new domains, study types, controlled terminology, and new approaches to representing familiar data. The instinct for many organizations is to treat readiness as a d

Your team knows the rules. You understand ALCOA+, 21 CFR Part 11, and what an inspection agenda looks like. But when the inspector sits down, one question decides how the day goes: can you demonstrate control, not just describe it? Knowing the rules and p

Your lab systems are validated. Your instruments have audit trails. Your databases follow 21 CFR Part 11. On paper, you've done everything right. So why does compliance still feel fragmented? The answer lies in the gaps between your systems, the spaces wh

Launching in 2027, Insights is a study data intelligence platform that helps nonclinical scientists connect, explore and interpret complex toxicology data in one unified environment. Designed around the way toxicologists and study directors review studies

For many years, Oracle databases have served as the foundation for scientific data management platforms across pharmaceutical, biotechnology, CRO, and research organizations. Their reliability, scalability, and enterprise-grade capabilities made them a na

Applicability domain gives a prediction context A (Quantitative) Structure-Activity Relationship (Q)SAR result needs context before it can support a regulatory conclusion. For mutagenicity assessment under ICH M7, one part of that context is the applicabi

For many quality and compliance teams, a regulatory inspection triggers a familiar and disruptive pattern. Skilled personnel find themselves pulled away from their usual responsibilities to search for the correct version of a file, compile audit trails fr