Skip to main content

Posts

Showing posts from January, 2023

What is the difference between SDTM and ADaM?

  Two important standards are supported by   CDISC : SDTM (Study Data Tabulation Model) and ADaM. (Analysis Data Model). Although the adoption of CDISC standards may increase development costs, you can reduce those costs by choosing the appropriate technology and implementation strategy. SDTM and ADaM datasets in the adoption of CDISC standards not only simplifies procedures but also stimulates innovation, efficiency, betters data quality, reduces costs, and boosts predictability. In comparison to SDTM and SEND, CDISC’s Analysis Data Model (ADaM) is a little different. Although the model is less prescriptive, it still comprises a core model and an implementation guide. Within specific limitations established by the model, more variables may be added. This provides a level of standardization that enables it to be easily understood by reviewers, while giving it the flexibility to be used for any type of study. This article was originally taken from PointCross:  SDTM - All ...

FDA SEND Dataset Services

The U.S. Food and Drug Administration ( FDA ) requires SEND as a standard for nonclinical study data submission to the Center for Drug Evaluation and Research (CDER). SEND is a data standard mandate of CDISC  SDTM  standard for nonclinical studies and provides a framework to collect and present individual animal study data. PointCross works with several Sponsors’ and CROs to support in preparation of submission ready SEND datasets with Define.xml and nSDRG, at industry’s most competitive rate.