Regulatory SubmissionSENDSensible SEND
So, what’s happening in SEND?
Marc Ellison
Aside from implementation of the Genetox IG, the other main activity that is currently advancing is SEND v4.0.
Sensible SEND Blog
Regulatory SubmissionSENDSensible SEND
The Hot SEND Topics from ACT 2023
Marc Ellison
People are now more focused on the uses of SEND beyond submission, as well as seeing the scope of SEND widening further as we close out the year.
Regulatory SubmissionSENDSensible SEND
What did the FDA tell us about the issues with Safety Pharm studies in SEND?
Marc Ellison
The FDA have been describing some of the issues that they are seeing with the SEND packages for safety pharmacology studies.
Regulatory SubmissionSENDSensible SEND
What is the impact of the latest FDA presentation for SEND 3.1 and 3.1.1?
Marc Ellison
What is the big deal with requiring juvenile studies in SEND v3.1/3.1.1?
Regulatory SubmissionSENDSensible SEND
Should you change your lexicons to SEND terminology?
Marc Ellison
There are advantages to aligning our nonclinical lexicons with the SEND CT terms, but there are potential pitfalls and things to consider too.
Regulatory SubmissionSENDSensible SEND
Metadata Magic! Data Warehousing with SEND
Marc Ellison
Dr Brenda Finney shares her thoughts on the use of SEND for data exchange in data warehouses like our Centrus platform which is built on the ToxHub database.
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