In 2007, a representative from Charles River joined the CDISC SEND team and was nominated as the SEND Findings Sub-Team Lead in 2008. We remain deeply involved with piloting SEND datasets with our sponsors and the FDA. By being a part of the CDISC SEND team, we were profoundly involved with the development of the CDISC SEND Implementation Guide (SENDIG) Version 3.0.
Charles River completed the validation of the SEND Suite to produce SEND data in February 2015 for all studies conducted using our global data capture system. SEND data can be produced for single dose, repeat-dose and carcinogenicity studies as per the SENDIG.
This resource covers key aspects of CDISC SEND and its effect on NDA/ANDA/BLA submissions to the FDA starting Dec 18, 2016.
We have been piloting SEND data with our sponsors throughout the course of the validation in order to test the datasets and processes.
For more detailed information about Charles River and the SEND initiative, contact us at [email protected].