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 Submission Blog
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.
Regulatory SubmissionSENDSensible SEND
Stop me if you’ve heard this one before…
Marc Ellison
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...
Regulatory SubmissionSENDSensible SEND
Submission implications of the new SEND standards
Marc Ellison
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.
Regulatory SubmissionSENDSensible SEND
New SEND standards from CDISC
Marc Ellison
The SENDIG-DART v1.2 and SENDIG-Genetox v1.0 Implementation Guides (IGs) plus their accompanying Conformance Rules are published.
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