In the world of SEND, there are main topics that keep reoccurring. Subjects that need revisiting partly with fresh impetus but mainly because these are the things that keep cropping up and become the main...
In this post we discuss the submission implications of the publication of the new implementation guides for SENDIG-Genetox v1.0 and SENDIG-DART v1.2.
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?
