![]() The ultimate goal is to phase out paper based submissions. Standardized data formats gives organizations the opportunity to: This will also increase the efficiency and quality of scientific review by the pharmacologists and toxicologists at the FDA’s Center for Drug Evaluation (CDER). Importantly, it will improve communication between regulatory authorities and sponsors. Using SEND standardizes electronic data transfer thereby making it easier to transfer data between organizations. SEND is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for non-clinical studies. The model supports the submission of non-clinical data to Regulatory Agencies such as the FDA and Japanese PMDA. SEND (Standard Exchange of Non-Clinical Data) is one of the data models developed by the Clinical Data Interchange Standards Consortium (CDISC). What exactly are CDISC data standards and how will they impact drug developers? In this blog post, I will provide an overview of the CDISC SEND data standard, review some of the requirements for implementing SEND, and discuss a solution that supports SEND compliance. On December 18, 2016, numerous regulatory agencies will require electronic submission of non-clinical data using CDISC’s standard format.
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