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SDTM Mapping
SDTM mapping is the process of converting clinical trial data from a study-specific format to the Study Data Tabulation Model (SDTM) format. SDTM is a standard for the submission of clinical trial data to regulatory agencies such as the US Food and Drug Administration (FDA). SDTM mapping involves mapping the data collected in a clinical trial to the standard SDTM domains, which are defined by the Clinical Data Interchange Standards Consortium (CDISC).
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How to generate SEND form nonclinical study?
The type of your nonclinical study and the regulatory agency you are submitting the data will determine the precise specifications for generatingĀ a SEND (Standard for Exchange of Nonclinical Data) form. Generally speaking, a group of skilled data managers, statisticians, and regulatory affairs experts produce SEND forms.
PointCross Lifesciences canĀ generate SEND form your nonclinical study
It is crucial to make sure that whoever creates the SEND form is knowledgeable about the proper standards and regulations for submitting nonclinical data and has a complete understanding of your study's design, data collection procedures, and analytical approaches.
How to generate SEND form nonclinical study?
The type of your nonclinical study and the regulatory agency you are submitting the data will determine the precise specifications for generatingĀ a SEND (Standard for Exchange of Nonclinical Data) form. Generally speaking, a group of skilled data managers, statisticians, and regulatory affairs experts produce SEND forms.
PointCross Lifesciences canĀ generate SEND form your nonclinical study
It is crucial to make sure that whoever creates the SEND form is knowledgeable about the proper standards and regulations for submitting nonclinical data and has a complete understanding of your study's design, data collection procedures, and analytical approaches.