by Instem Team | Sep 15, 2026 | Resources
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 downstream...
by Instem Team | Sep 10, 2026 | Compliance Builder, Study Management
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 proving...
by Instem Team | Sep 8, 2026 | Compliance Builder, Study Management
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 where...
by Instem Team | Sep 4, 2026 | In Silico & Data Insights
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, Insights...
by Instem Team | Aug 27, 2026 | BioRails, Study Management
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 natural choice...
