The SENDIG-DART v1.2 and SENDIG-Genetox v1.0 Implementation Guides (IGs) plus their accompanying Conformance Rules are published.
The relationship between the SEND Implementation Guide and the FDA’s Technical Conformance Guide has become more symbiotic than we previously anticipated.
We work in a highly risk-averse industry where even software upgrades are approached cautiously. SEND has driven huge change, but now AI and predictive toxicology are pushing boundaries even further. How do we balance risk...
What can our customers control that could help us make SEND faster and cheaper, without negatively impacting quality?
With the new Implementation Guide due to go on public review this coming August, we take a closer look at the scope of SEND 4.0.
The FDA has released a new version of the study data Technical Conformance Guide
